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NCT01789476 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study to Evaluate Analgesic Effect of IV CR845 For Pain Following Bunionectomy Surgery
A Phase 2 study of Acute Pain, sponsored by Cara Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT01789476: Completed Phase 2 study of Acute Pain, sponsored by Cara Therapeutics.
NCT01789476 is a Phase 2 study of Acute Pain that has completed, run by Cara Therapeutics. The registered enrollment target is 51 participants, below the 267-participant average among 50 other Acute Pain trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01789476, a Phase 2 study of Acute Pain, has completed, sponsored by Cara Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-center, randomized, double blind, placebo controlled, parallel group proof of concept study to evaluate the analgesic efficacy as well as the safety, tolerability and pharmacokinetic profile of CR845 in patients with pain following bunionectomy surgery.
Primary Outcome
Patients reported their pain intensity using a visual analogue scale (VAS) from 0 to 100 mm, where 0 mm represented "No Pain" and 100 mm represented the "Worst Pain You Can Imagine". SPID 0-24 represents the cumulative time-weighted sum of the pain intensity difference (PID) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 0 to 15 min, 15 to 30 min, etc.) over 24 hours. Pain intensity assessments were measured at baseline (entry pain score)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CR845
Study Locations (1)
Utah
- Jean Brown Research - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2013-05 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
What the finished NCT01789476 record still lists
NCT01789476 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 267-participant average among 50 other Acute Pain trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Acute Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01789476 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT01789476 about?
NCT01789476 is a clinical study titled "A Phase 2 Study to Evaluate Analgesic Effect of IV CR845 For Pain Following Bunionectomy Surgery". This is a single-center, randomized, double blind, placebo controlled, parallel group proof of concept study to evaluate the analgesic efficacy as well as the safety, tolerability and pharmacokinetic profile of CR845 in patients with pain following bunionectomy surgery.
What is the current status of trial NCT01789476?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2013-05. Estimated completion is 2013-08.
What conditions does trial NCT01789476 study?
This clinical trial studies the following conditions: Acute Pain.
What interventions are being tested in trial NCT01789476?
The interventions under investigation include: Placebo (DRUG), CR845 (DRUG).
Who is sponsoring clinical trial NCT01789476?
This trial is sponsored by Cara Therapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01789476 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01789476's enrollment target sits among peer trials
51 38th of 50 higher than 13 of 50 other Acute Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Pain 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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