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NCT01939366 · ClinicalTrials.gov registry record · Phase 2
Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves
A Phase 2 study of Chronic Pain and Diabetes Mellitus, sponsored by Tris Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 699
- Enrollment target
- 20
- Study locations
NCT01939366: Completed Phase 2 study of Chronic Pain and Diabetes Mellitus, sponsored by Tris Pharma.
NCT01939366 is a Phase 2 study of Chronic Pain and Diabetes Mellitus that has completed, run by Tris Pharma. The registered enrollment target is 699 participants, roughly in line with the 770-participant average among 301 other Chronic Pain trials with a reported enrollment target. The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01939366, a Phase 2 study of Chronic Pain and Diabetes Mellitus, has completed, sponsored by Tris Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 699 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this trial is to evaluate if cebranopadol is safe and can decrease pain in patients when compared to placebo (a tablet that does not contain active product) and when compared to a marketed product containing pregabalin (Lyrica®). Furthermore, this trial will be undertaken to find out if the patient's general health and well-being improves under trial treatment. The concentrations of cebranopadol in the blood will be investigated to get a better understanding of how it is absorbed from the gut, distributed and broken down in the body, and eliminated from the body.
Primary Outcome
Participants will be asked to record their pain intensity in the evening. Participants are asked to rate how much pain they had on average in the past 24 hours. The participant scores their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Baseline average pain scores are calculated from the averages of all scores recorded during the 3 days prior to randomization. The average pain at wee
Conditions Studied
Interventions
- DRUG Matching Placebo
- DRUG Pregabalin
- DRUG Cebranopadol 100 µg
- DRUG Cebranopadol 300 µg
- DRUG Cebranopadol 600 µg
Study Locations (20)
Other
- AT007 - Graz
- AT005 - Salzburg
- AT004 - Senftenberg
- AT002 - Vienna
- AT003 - Vienna
California
- US001 - Garden Grove
- US019 - Laguna Hills
- US014 - National City
- US007 - Orange
Florida
- US011 - Hialeah
- US012 - Miami
- US009 - Orlando
New York
- US008 - Brooklyn
- US005 - Brooklyn
- US021 - New York
Arizona
- US002 - Mesa
Idaho
- US004 - Blackfoot
Illinois
- US006 - Elgin
New Jersey
- US016 - West Long Branch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 699 participants |
| Start Date | 2013-09-27 |
| Est. Completion | 2015-01-28 |
| Phase | Phase 2 |
What the finished NCT01939366 record still lists
NCT01939366 is an interventional study that assigns participants to a tested intervention. The registered 699 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 770-participant average among 301 other Chronic Pain trials with a reported enrollment target.
The record links to 3 conditions, with Chronic Pain appearing as the primary indexed condition, and to 5 interventions - of which Matching Placebo is the first listed.
NCT01939366 names 20 study sites across 9 states, led by Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01939366 about?
NCT01939366 is a clinical study titled "Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves". The purpose of this trial is to evaluate if cebranopadol is safe and can decrease pain in patients when compared to placebo (a tablet that does not contain active product) and when compared to a marketed product containing pregabalin (Lyrica®). Furthermore, this trial will be undertaken to find out ...
What is the current status of trial NCT01939366?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 699 participants. The study started on 2013-09-27. Estimated completion is 2015-01-28.
What conditions does trial NCT01939366 study?
This clinical trial studies the following conditions: Chronic Pain, Diabetes Mellitus, Diabetic Neuropathies.
What interventions are being tested in trial NCT01939366?
The interventions under investigation include: Matching Placebo (DRUG), Pregabalin (DRUG), Cebranopadol 100 µg (DRUG), Cebranopadol 300 µg (DRUG), Cebranopadol 600 µg (DRUG).
Who is sponsoring clinical trial NCT01939366?
This trial is sponsored by Tris Pharma, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01939366 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01939366's enrollment target sits among peer trials
699 15th of 301 higher than 287 of 301 other Chronic Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic 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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