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NCT02944448 · ClinicalTrials.gov registry record · Phase 2
A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee
A Phase 2 study, sponsored by Cara Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 761
- Enrollment target
NCT02944448 is a Phase 2 study that has completed, run by Cara Therapeutics. The registered enrollment target is 761 participants.
The verdict
NCT02944448, a Phase 2 study, has completed, sponsored by Cara Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 761 participants
- Enrollment target
Study Summary
The study schedule consists of a Screening Period (up to 14 days), a blinded 4- week Titration-to-Effect Period with weekly visits, a blinded 4-week Maintenance Treatment Period at the optimal dose level determined for each patient, and a 1-week Follow-up Period. Eligible patients will be randomized to receive either CR845 or placebo in a 2:1 ratio. Every patient will be started on a 1-mg dose of CR845 or matching placebo. During the post-randomization Titration-to-Effect period, the dose of study drug may be increased to 2.5 mg or 5 mg in a double-blind fashion. Patients may know their dose is being changed but will not know whether they were randomization to active study drug or placebo. Approximately 330 patients will be enrolled in this study.
Interventions
- DRUG Placebo tablet
- DRUG CR845 tablet 1 mg
- DRUG CR845 tablet 2.5 mg
- DRUG CR845 tablet 5 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 761 participants |
| Start Date | 2016-09 |
| Est. Completion | 2017-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02944448
The ClinicalTrials.gov registry entry for NCT02944448 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 761 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cara Therapeutics, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo tablet is the first listed.
NCT02944448 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02944448 about?
NCT02944448 is a clinical study titled "A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee". The study schedule consists of a Screening Period (up to 14 days), a blinded 4- week Titration-to-Effect Period with weekly visits, a blinded 4-week Maintenance Treatment Period at the optimal dose level determined for each patient, and a 1-week Follow-up Period. Eligible patients will be randomize...
What is the current status of trial NCT02944448?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 761 participants. The study started on 2016-09. Estimated completion is 2017-06.
What interventions are being tested in trial NCT02944448?
The interventions under investigation include: Placebo tablet (DRUG), CR845 tablet 1 mg (DRUG), CR845 tablet 2.5 mg (DRUG), CR845 tablet 5 mg (DRUG).
Who is sponsoring clinical trial NCT02944448?
This trial is sponsored by Cara Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
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