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NCT02682511 · ClinicalTrials.gov registry record · Phase 2
Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension
A Phase 2 study of Autoimmune Diseases and Skin Diseases, sponsored by Cumberland Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 13
- Study locations
NCT02682511: Active Phase 2 study of Autoimmune Diseases and Skin Diseases, sponsored by Cumberland Pharmaceuticals.
NCT02682511 is a Phase 2 study of Autoimmune Diseases and Skin Diseases that is active but no longer recruiting, run by Cumberland Pharmaceuticals. The registered enrollment target is 34 participants, below the 977-participant average among 25 other Autoimmune Diseases trials with a reported enrollment target (97% lower). The trial reports 13 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02682511, a Phase 2 study of Autoimmune Diseases and Skin Diseases, is active but no longer recruiting, sponsored by Cumberland Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 13
- Study locations
Study Summary
The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic SSc (dcSSc) or SSc-associated pulmonary arterial hypertension (SSc-PAH).
Primary Outcome
Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of ifetroban.
Conditions Studied
Interventions
- DRUG Oral Placebo
- DRUG Oral Ifetroban
Study Locations (13)
Maharashtra
- KDH - Kokilaben Dhirubhai Ambani Hospital - Mumbai
- B. J. Government Medical College - Pune
Arizona
- The Universtity of Arizona Arthrtis Center - Tucson
California
- UCLA - Los Angeles
Florida
- Cleveland Clinic - Florida - Weston
Maryland
- Johns Hopkins University - Baltimore
Massachusetts
- Massachusetts General Hospital - Boston
Nebraska
- University of Nebraska Medical Center - Omaha
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2017-01 |
| Est. Completion | 2026-05 |
| Phase | Phase 2 |
What the registry record for NCT02682511 still lists
NCT02682511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 977-participant average among 25 other Autoimmune Diseases trials with a reported enrollment target (97% lower).
The record links to 8 conditions, with Autoimmune Diseases appearing as the primary indexed condition, and to 2 interventions - of which Oral Placebo is the first listed.
NCT02682511 lists 13 locations in 12 states (Maharashtra, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT02682511 about?
NCT02682511 is a clinical study titled "Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension". The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic SSc (dcSSc) or SSc-associated pulmonary arterial hypertension (SSc-PAH).
What is the current status of trial NCT02682511?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2017-01. Estimated completion is 2026-05.
What conditions does trial NCT02682511 study?
This clinical trial studies the following conditions: Autoimmune Diseases, Skin Diseases, Pathologic Processes, Scleroderma, Systemic, Connective Tissue Diseases.
What interventions are being tested in trial NCT02682511?
The interventions under investigation include: Oral Placebo (DRUG), Oral Ifetroban (DRUG).
Who is sponsoring clinical trial NCT02682511?
This trial is sponsored by Cumberland Pharmaceuticals, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02682511 being conducted?
This trial has 13 study locations across Arizona, California, Florida, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02682511's enrollment target sits among peer trials
34 18th of 25 higher than 8 of 25 other Autoimmune Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autoimmune Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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