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NCT01709214 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain
A Phase 2 study, sponsored by Tris Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 619
- Enrollment target
NCT01709214 is a Phase 2 study that has completed, run by Tris Pharma. The registered enrollment target is 619 participants.
The verdict
NCT01709214, a Phase 2 study, has completed, sponsored by Tris Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 619 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of GRT6005 compared to placebo in patients with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. This study includes a maximum 21 day Screening Period followed by a 15-week Double-blind Treatment Period and a 4-7 day Safety Follow-up period. Patients who are eligible for the Double-blind Treatment Period will be randomized to one of following treatment groups: GRT6005 high-dose range (400, 600 or 800 mcg), GRT6005 low-dose range (200, 300 or 400 mcg), oxycodone controlled release (CR) dose range (10, 20, 30, 40 or 50 mg) or placebo.
Interventions
- DRUG Placebo
- DRUG Oxycodone CR
- DRUG Cebranopadol (GRT6005) Low-Dose Range
- DRUG Cebranopadol (GRT6005) High-Dose Range
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 619 participants |
| Start Date | 2012-12-04 |
| Est. Completion | 2014-04-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01709214
The ClinicalTrials.gov registry entry for NCT01709214 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 619 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tris Pharma, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01709214 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01709214 about?
NCT01709214 is a clinical study titled "Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain". The purpose of this study is to evaluate the safety and efficacy of GRT6005 compared to placebo in patients with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. This study includes a maximum 21 day Screening Period followed by a 15-week Double-blind Treatment Period and a 4-7...
What is the current status of trial NCT01709214?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 619 participants. The study started on 2012-12-04. Estimated completion is 2014-04-04.
What interventions are being tested in trial NCT01709214?
The interventions under investigation include: Placebo (DRUG), Oxycodone CR (DRUG), Cebranopadol (GRT6005) Low-Dose Range (DRUG), Cebranopadol (GRT6005) High-Dose Range (DRUG).
Who is sponsoring clinical trial NCT01709214?
This trial is sponsored by Tris Pharma, which has 14 total clinical trials registered on ClinicalTrials.gov.
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