Trial record 1 of 1 for:
NCT04684511
Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy (RESET-HA)
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| ClinicalTrials.gov Identifier: NCT04684511 |
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Recruitment Status :
Terminated
(Low enrollment. The termination of the trial was not based on any safety concerns in the study.)
First Posted : December 24, 2020
Last Update Posted : October 27, 2022
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Sponsor:
Tremeau Pharmceuticals, Inc.
Information provided by (Responsible Party):
Tremeau Pharmceuticals, Inc.
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Brief Summary:
This is a multicenter, randomized, double-blind study to evaluate the efficacy and safety of TRM-201 (rofecoxib) versus Placebo in the treatment of patients with hemophilic arthropathy (HA) over a 12-week period (Part I) that is followed by a year-long (52 week) open-label extension (Part II) to further evaluate the safety and maintenance of efficacy of TRM-201.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hemophilic Arthropathy | Drug: TRM-201 (Rofecoxib) Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Study With a Long-Term, Open-Label Extension to Evaluate the Efficacy and Safety of TRM-201 (Rofecoxib) in Patients With Hemophilic Arthropathy |
| Actual Study Start Date : | June 2, 2021 |
| Actual Primary Completion Date : | September 28, 2022 |
| Actual Study Completion Date : | September 28, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Joint Disorders
| Arm | Intervention/treatment |
|---|---|
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Experimental: TRM-201 (Rofecoxib)
1 TRM-201 tablet taken orally once daily for 12 weeks in Part I and orally once daily for an additional 52 weeks in Part II
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Drug: TRM-201 (Rofecoxib)
Eligible patients will be randomized to receive TRM-201 or placebo
Other Name: Placebo |
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Placebo Comparator: Placebo
1 placebo tablet (to match TRM-201) taken orally once daily for 12 weeks in Part I and then 1 TRM-201 tablet taken orally once daily for an additional 52 weeks in Part II
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Drug: Placebo
Matching Placebo |
Primary Outcome Measures :
- The change from baseline in the patient assessment of the daily Average Hemophilic arthropathy Pain Intensity score on a 0- to 10-point numeric rating scale where 0 = no pain and 10 = pain as bad as you can imagine. [ Time Frame: 12 weeks ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 12 Years to 75 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of hemophilia A or B
- Either on a stable prophylaxis regimen for their bleeding disorder (factor, bypassing agent, or nonfactor product therapy) OR currently taking or agree to initiate a gastroprotective agent (esomeprazole) for the duration of the trial
- Diagnosis of Hemophilic Arthopathy for at least 6 months prior to screening
- Chronic symptomatic pain in one or more joint(s) on 20 of the 30 days prior to screening.
- Able and willing to wash out of non-study analgesic medications/agents for at least 7 days prior to Randomization including: acetaminophen (paracetamol), NSAIDs, opioids, cannabinoids, topical analgesics, benzodiazepines, gabapentin/pregabalin-containing products and other antiepileptic drugs used for pain
- Primary source of pain is due to Hemophilic Arthropathy
Exclusion Criteria:
- Taking opioids for greater than 4 days per week prior to screening
- Has a history of advanced renal disease or severe liver disease (within the last 6 months)
- Receiving emicizumab while also receiving activated prothrombin complex concentrate (FEIBA)
- Uncontrolled or poorly controlled hypertension
- History of major cardiac or cerebrovascular disease
- History of an upper GI perforation, obstruction, or major GI bleed or current evidence of GI bleeding
- Has active hepatitis C or hepatitis B infection or uncontrolled HIV. Note: Patients who are HIV positive are allowed to participate if considered to be controlled.
- Has a positive drug screen for all prohibited drugs of potential abuse at screening
- Has had an intra-articular injection (within 3 months), initiated physical therapy (within 30 days) or has had orthopedic surgery (within 4 months) prior to screening
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04684511
Locations
Show 46 study locations
Sponsors and Collaborators
Tremeau Pharmceuticals, Inc.
Investigators
| Study Director: | Judith Boice, PhD | Tremeau Pharmaceuticals |
| Responsible Party: | Tremeau Pharmceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT04684511 |
| Other Study ID Numbers: |
TRM-201-HA-301 |
| First Posted: | December 24, 2020 Key Record Dates |
| Last Update Posted: | October 27, 2022 |
| Last Verified: | August 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Tremeau Pharmceuticals, Inc.:
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Hemophilia Pain HA Joint Pain |
Additional relevant MeSH terms:
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Joint Diseases Musculoskeletal Diseases Rofecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents |