A Randomized, Double-Blinded, Placebo-Controlled Phase I Study to Evaluate the Safety and Efficacy of Ampion in Patients With Prolonged Respiratory Symptoms Due to COVID-19 (Long COVID)

This is a phase I study to evaluate the safety and efficacy of inhaled Ampion on patients with prolonged respiratory symptoms due to COVID-19 (Long COVID).

Start Date26 Jul 2021

Sponsor / Collaborator

Ampio Pharmaceuticals, Inc.

NCT04839965

/ TerminatedPhase 2

A Randomized, Double-Blinded, Placebo Controlled Phase II Study to Evaluate the Safety and Efficacy of IV Ampion in Adult COVID-19 Patients Requiring Oxygen Supplementation

This is a Phase 2 randomized study to evaluate the safety and efficacy of IV Ampion in improving the clinical course and outcomes of adult COVID-19 patients requiring supplemental oxygen.

Start Date05 Jul 2021

Sponsor / Collaborator

Ampio Pharmaceuticals, Inc.

NCT04868890

/ TerminatedPhase 2

A Randomized, Double-Blinded, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19

This is phase II study to evaluate the safety and efficacy of inhaled Ampion in adults with respiratory distress due to COVID-19

Start Date22 Jun 2021

Sponsor / Collaborator

Ampio Pharmaceuticals, Inc.

100 Clinical Results associated with Aspartyl-alanyl-diketopiperazine

100 Translational Medicine associated with Aspartyl-alanyl-diketopiperazine

100 Patents (Medical) associated with Aspartyl-alanyl-diketopiperazine

Literatures (Medical) associated with Aspartyl-alanyl-diketopiperazine

01 Oct 2024·BMJ Open

Real-world usage pattern, effectiveness and safety of oral tramadol/dexketoprofen trometamol fixed-dose combination in moderate-to-severe acute pain in Asia: a prospective, multicentre, observational study

Article

Author: Gupta, Ankur ; Nagrale, Dinesh ; Tangwiwat, Suwimon ; Castro, Marc Anthony L ; Raju, Gopinathan ; Eufemio, Edgar Michael ; Sawaddiruk, Passakorn ; Ho, Kok Yuen ; Ona, Leonardo ; Chong, Keen Wai ; Dimayuga, Cesar ; Salvador, Roehl C ; Waithayayothin, Kritsadakorn ; Gyanwali, Bibek ; Roohi, Sharifah Ahmad ; Bernardo, Edwin ; Wilairatana, Vajara ; Oon, Zhi Hao

Objectives:

This study aims to determine the usage pattern, effectiveness and safety of oral tramadol 75 mg and dexketoprofen trometamol 25 mg fixed-dose combination (TRAM/DKP FDC) in the short-term treatment of moderate-to-severe acute pain in real-world clinical practice in Asia.

Design:

Real-world, prospective, multicentre, observational, phase IV study.

Setting:

13 tertiary-care hospital sites across the Philippines, Thailand, Malaysia and Singapore.

Participants:

Adult patients aged 18–80 years prescribed TRAM/DKP FDC for the short-term (up to 5 days) treatment of moderate-to-severe acute pain.

Main outcome measures:

Primary endpoints were the proportion of patients prescribed TRAM/DKP FDC with different types of postsurgical and non-surgical treatments, and the average dosing frequency and duration of TRAM/DKP FDC treatment. Secondary endpoints were the proportion of patients achieving ≥30% pain reduction at 8 hours post the first dose (pain severity was assessed using the 11-point Numeric Pain Rating Scale); patient satisfaction at the end of treatment (based on a 5-point Patient Global Evaluation Scale (PGE)) and safety including the incidence of adverse drug reactions (ADRs).

Results:

Among 599 patients (median age 44 years, 61.3% female) enrolled in this study, 68.61% (n=411) were postsurgical and 31.39% (n=188) were non-surgical patients. TRAM/DKP FDC was prescribed in a diverse group of postsurgical patients (eg, orthopaedic, general and cancer surgery) as well as in non-surgical conditions (eg, lower back pain and musculoskeletal pain). In the majority of patients, TRAM/DKP FDC was prescribed every 8 hours (65.94%) and for 5 days (78.80%). There was a significant reduction in pain intensity throughout the study and 65% of patients achieved ≥30% pain reduction from baseline at 8 hours post the first dose of TRAM/DKP FDC on day 1. 95.69% of patients were satisfied with the treatment (rated good, very good and excellent on the PGE scale). Overall, 13.9% of patients reported ADRs; most were mild to moderate in severity. The most common ADRs were nausea, vomiting and dizziness.

Conclusion:

This study showed that TRAM/DKP FDC was used in diverse types of postsurgical and non-surgical patients in the real-world setting in Asia. It effectively reduced pain and was well tolerated with a high level of patient satisfaction.

01 Aug 2024·Pain and Therapy

Dexketoprofen Trometamol and Tramadol Hydrochloride Fixed-Dose Combination in Moderate to Severe Acute Low Back Pain: A Phase IV, Randomized, Parallel Group, Placebo, Active-Controlled Study (DANTE)

Article

Author: Brotons, Carles ; Hanna, Magdi ; Baldini, Simone ; Perrot, Serge ; Kruljac, Ivan ; Fabrizzi, Paolo ; Coaccioli, Stefano ; Varrassi, Giustino

INTRODUCTION:

Dexketoprofen/tramadol 25/75 mg (DKP/TRAM) is a fixed-dose combination of a cyclooxygenase inhibitor and opioid receptor agonist. To better understand the efficacy and safety of DKP/TRAM in the treatment of moderate to severe acute lower back pain (LBP) with or without radiculopathy, we carried out a large explorative phase IV international, multicenter, prospective, randomized, double-blind, parallel group, placebo-controlled study (DANTE).

METHODS:

A total of 538 patients with or without a history of LBP and experiencing acute LPB of moderate to severe intensity [Numerical Rating Scale-Pain Intensity (NRS-PI) score > 5] were randomized 4:4:1:1 to DKP/TRAM 25/75 mg every 8 h (n = 211), tramadol (TRAM) 100 mg (n = 207), placebo-matched DKP/TRAM (n = 59), or placebo-matched TRAM (n = 61).

RESULTS:

The proportion of patients achieving the primary endpoint, defined as the time to first achieve NRS-PI score < 4 or pain intensity reduction ≥ 30% from drug intake up to 8 h after the first dose, was higher in the DKP/TRAM arm than in the placebo group, but the difference was not statistically significant (46.1% vs. 42.6%, respectively; hazard ratio 1.11; 95% confidence interval 0.775, 1.595; p = 0.566). DKP/TRAM achieved superiority over TRAM in total pain relief at 4, 6, and 8 h (p < 0.05). Conversely, in relation to the secondary endpoints, a significantly greater reduction in NRS-PI score was seen with DKP/TRAM versus placebo starting from 1 h, and this reduction remained numerically lower throughout 8 h. Summed pain intensity difference values were also significantly lower at 4, 6, and 8 h with DKP/TRAM compared to TRAM (p < 0.05). Overall, DKP/TRAM was well tolerated.

CONCLUSION:

Although the primary endpoint was not met, secondary efficacy analyses suggest the superiority of DKP/TRAM over placebo and TRAM alone in terms of total pain relief. DKP/TRAM can be considered to be an effective and safe option for the treatment of moderate to severe acute LBP.

DANTE STUDY REGISTRATION:

EudraCT number: 2019-003656-37; ClinicalTrials.gov Identifier: NCT05170841.

01 May 2024·Hip international : the journal of clinical and experimental research on hip pathology and therapy

Pain management after total hip arthroplasty: comparative study of analgesic efficacy and tolerability between oral tramadol/dexketoprofen and injectable paracetamol + tramadol

Article

Author: Macheras, George A ; Gálvez Miravete, Alejandro ; Argyrou, Chrysoula ; Nikolakopoulou, Elena ; Karachalios, Thefilos S ; Tzefronis, Dimitrios

Background::

Multimodal analgesia for total hip arthroplasty (THA) is increasingly employed to reduce early postoperative pain and promote fast patient discharge. The aim of this study was to compare the efficacy and tolerability of tramadol/dexketoprofen (TRAM/DKP, Group A) versus paracetamol + tramadol (PARA+TRAM, Group B) in patients undergoing THA using minimally invasive direct anterior approach (DAA).

Methods::

A single-centre, randomised, single-blind, parallel, interventional study conducted in 323 patients undergoing primary THA with DAA was performed. Group A consisted of 188 patients and Group B of 135. The primary endpoints were the change from baseline (measured 2 hours postoperatively) in pain intensity (PI) during the treatment period (48 hours), assessed by visual analogue scale (VAS) at pre-specified postoperative time-points (2, 8, 24, 48 hours) and the total rescue medication (RM) use during the first 24 hours postoperatively.

Results::

As early as 2 hours after baseline, Group A showed a greater PI reduction from baseline compared to Group B (−26.24% vs. −6.87%; p < 0.001). A lower mean PI (VAS) score was consistently found over the entire observation period following treatment with TRAM/DKP than with PARA+TRAM as well as more than 2-fold higher proportion of responders at the end of treatment period. More patients in Group B required RM in comparison to those in Group A (15.6% vs. 3.7%, p < 0.001). Both treatments were well tolerated.

Conclusions::

After THA, oral TRAM/DKP provides faster and greater pain relief when compared to intravenous PARA+TRAM with limited consumption of RM and favourable tolerability profile. Our study expands the use of TRAM/DKP in the setting of major orthopaedic surgeries.

Clinical trial registration::

clinicaltrials.gov (NCT04178109)

News (Medical) associated with Aspartyl-alanyl-diketopiperazine

28 Oct 2021

·www.biospace.com

Ampio Pharmaceuticals, Inc. to Report Fiscal 2021 Third Quarter Financial Results and Provide Corporate Business Update

ENGLEWOOD, Colo., Oct. 28, 2021 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced it will host a conference call to discuss financial results for the quarter ended September 30, 2021 and provide a corporate business update on Wednesday, November 10, 2021, at 4:30 pm EDT/ 2:30 pm MT. Conference Call & Webcast: Wednesday, November 10, 2021, 4:30 pm EDT / 2:30 pm MT Webcast Link: Conference Call (listen only): Canada dial-in number (Toll Free): 1 833 950 0062 Canada dial-in number (Local): 1 226 828 7575 United States: 1 844 200 6205 United States (Local): 1 646 904 5544 All other locations: +1 929 526 1599 Access code: 385971 In order to submit questions, participants must have internet connectivity, as questions will only be addressed via the webcast. The conference call line will be in listen only mode. The conference call and webcast can also be accessed from the Investor Relations section of the Company's website at and will be archived there shortly after the live event. About Ampio Pharmaceuticals Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion™, is backed by an extensive patent portfolio with intellectual property protection extending through 2037 and may be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the Biologics Price Competition and Innovation Act (BPCIA). Forward Looking Statements Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise. Company Codes: AMEX:AMPE

Financial StatementLicense out/in

21 Sep 2021

·www.biospace.com

Ampio Pharmaceuticals Receives Approval from the Drugs Controller General of India (DCGI) to Commence AP-019 Phase II Study in India

ENGLEWOOD, Colo., Sept. 21, 2021 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced regulatory approval from the Drugs Controller General of India (DCGI) of the Central Drugs Standard Control Organization (CDSCO) in the Phase II AP-019 clinical trial in India. The study will utilize inhaled Ampion™ to treat those suffering from respiratory distress due to COVID-19. Following presentation of Ampion to a Subject Expert Committee (SEC) established by the DCGI, the AP-019 treatment protocol was approved with no recommended changes. "More than a year and a half into the pandemic, healthcare practitioners still lack effective and easy-to-use therapies to treat the severe and often fatal respiratory distress experienced by many COVID-19 patients," said Mike Macaluso, President & CEO of Ampio. "We are grateful for the DCGI's swift attention and believe their decision underscores the critical medical need for Ampion as a potential treatment option." India has experienced over 33 million infections and over 440 thousand reported coronavirus-related deaths since the pandemic began, making it the country with the largest number of COVID-19 infections and deaths in the Middle East and Asia. While new infections are at 10% of their peak in early May, COVID-19 remains a continuing health threat in India. As an immunomodulatory agent with anti-inflammatory effects, Ampion interrupts the hyperactive immune response associated with COVID-19 and, as such, may improve the clinical outcome for patients suffering from its complications. Directly administering Ampion to patients by inhalation allows the drug to directly target and attenuate inflammation in the lungs. The company initiated the AP-019, double-blind, placebo-controlled Phase II trial, utilizing inhaled Ampion following the strong top-line results achieved from its AP-014 Phase I trial. On April 27, 2021, the company reported the earlier Phase I study not only met its primary endpoint of safety and tolerability, but top-line results also showed that Ampion reduced all-cause mortality in COVID-19 respiratory distress by 78% over the Standard of Care (SOC) for patients suffering from respiratory distress due to COVID-19. Specifically, mortality in the SOC group was 24%, while in the group treated with SOC and Ampion, mortality was only 5%. About Ampio Pharmaceuticals Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion™, is backed by an extensive patent portfolio with intellectual property protection extending through 2037 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the Biologics Price Competition and Innovation Act (BPCIA). Forward Looking Statements Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise. Media Contact Katie Kennedy katiek@gregoryfca.com 610-731-1045 Company Codes: AMEX:AMPE

License out/in

14 Jul 2021

·www.biospace.com

Ampio Pharmaceuticals, Inc. to Report Fiscal 2021 Second Quarter Financial Results and Provide Corporate Business Update

ENGLEWOOD, Colo., July 14, 2021 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced it will host a conference call to discuss financial results for the quarter ended June 30, 2021, and provide a corporate business update on Wednesday, August 4, 2021, at 4:30 pm EDT/ 2:30 pm MT. The conference call will also be available from the Investor Relations section of the Company's website at and will be archived there shortly after the live event. About Ampio Pharmaceuticals Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies to treat prevalent inflammatory conditions for which there are limited treatment options. Ampio's lead drug, Ampion™, is backed by an extensive patent portfolio with intellectual property protection extending through 2037 and will be eligible for 12-year FDA market exclusivity upon approval as a novel biologic under the biologics price competition and innovation act (BPCIA). Forward Looking Statements Ampio's statements in this press release that are not historical fact, and that relate to future plans or events, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "plan," "anticipate," and similar expressions. These forward-looking statements include statements regarding Ampio's expectations with respect to Ampion and its classification, as well as those associated with regulatory approvals and other FDA decisions, the Biological License Application (BLA), the ability of Ampio to enter into partnering arrangements, clinical trials and decisions and changes in business conditions and similar events, the ability to receive regulatory approval to conduct clinical trials, that Ampion may be used to treat ARDS induced by COVID-19, all of which are inherently subject to various risks and uncertainties. The risks and uncertainties involved include those detailed from time to time in Ampio's filings with the Securities and Exchange Commission, including without limitation, under Ampio's Annual Report on Form 10-K and other documents filed with the Securities and Exchange Commission. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise. Company Codes: AMEX:AMPE

Financial StatementLicense out/in

100 Deals associated with Aspartyl-alanyl-diketopiperazine

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Pain	Phase 3	US	Ampio Pharmaceuticals, Inc.	19 Jun 2017
Osteoarthritis, Knee	Phase 3	-	Ampio Pharmaceuticals, Inc.	01 Jan 2014
Pain	Phase 3	-	Ampio Pharmaceuticals, Inc.	01 Jan 2014
COVID-19	Phase 2	US	Ampio Pharmaceuticals, Inc.	22 Jun 2021
Respiratory Distress Syndrome	Phase 2	US	Ampio Pharmaceuticals, Inc.	22 Jun 2021
Post Acute COVID 19 Syndrome	Phase 1	US	Ampio Pharmaceuticals, Inc.	26 Jul 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04880161 (CTgov)	Phase 1	Post Acute COVID 19 Syndrome	32	Ampion (Active)	yxkwstthdz(wkfjtoxoqg) = bqbdzilddz drguoexhgi (sojceszxab, qtabvvfcdt - nkqdsekrtq) View more	-	21 Sep 2023
				Placebo (Control)	yxkwstthdz(wkfjtoxoqg) = gvpdkvnjzb drguoexhgi (sojceszxab, uomqmkoxzq - atdlwbbwpa) View more
NCT04868890 (CTgov)	Phase 2	COVID-19 \| Respiratory Distress Syndrome	200	Ampion (Active)	glpgmbhmhb(hqekpoooaj) = tqtucnripy wgiowszthx (cmzeojmtyc, jampywhqdx - qsnkbxiozq) View more	-	07 Dec 2022
				Placebo (Control)	glpgmbhmhb(hqekpoooaj) = yjdpckfppe wgiowszthx (cmzeojmtyc, qizptgqtlp - raeshbjywl) View more
NCT04839965 (CTgov)	Phase 2	COVID-19	36	Ampion (IV Ampion)	kypzqctxfw(jzmpfgzllb) = gjfqgfwfdv bjzaciedni (gjhfxorhcf, aqicdphmmb - ywubtvovjb) View more	-	30 Nov 2022
				Saline (IV Placebo)	kypzqctxfw(jzmpfgzllb) = yikpfnvthx bjzaciedni (gjhfxorhcf, vuchmmmwjk - wmqhvyvjvo) View more
NCT03988023 (AP-013, PRNewswire) Manual	Phase 3	Osteoarthritis, Knee	725	Ampion	dukedgrtgz(owauwfsbue) = In addition, a separate statistical analysis of data from the 725 patients that the Company believed not to have been impacted by the pandemic demonstrated a statistically significant reduction in pain (p=0.0260) and improvement in function (p=0.0073) vbizrhkluq (efkfoigpdb )	Positive	15 Sep 2021
NCT04606784 (PRNewswire) Manual	Phase 1	COVID-19 respiratory infection	-	Standard of Care+Ampion	tubvvyykzm(knhgkgwwsj) = no remarkable adverse events with Ampion treatment, and no drug-related serious adverse events were reported hfzlsgnaeu (gfqlshakzy )	Positive	27 Apr 2021
				Standard of Care
NCT03182686 (AP-003-C, Pubmed \| Patient Saf Surg) Manual	Phase 3	Osteoarthritis, Knee	168	Aspartyl-alanyl-diketopiperazine	rbuyypsdhk(gokozcxgcb) = rmpsnrezox kdiygeidna (vvrcqsjerm, 63.4 - 78.3) View more	Positive	18 Jun 2018
				Placebo	dsgeoctqou(cqepplsqbw) = wlmyixfzsa lwjniwlgmd (jgcsgzbsbl )
NCT02556710 \| NCT02024529 (Pubmed \| Orthopedics)	Phase 3	Osteoarthritis, Knee	417	LMWF-5A	yxhdjrjiti(rjrtykryym) = lwpvnejctw binxryfgqq (prvjxbexnw )	Positive	01 Jan 2018
				Saline	yxhdjrjiti(rjrtykryym) = yzzeekfmju binxryfgqq (prvjxbexnw )

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