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NCT01240876 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Efficacy of Placulumab (CEP-37247) Administered by the Transforaminal Epidural Route for the Treatment of Patients With Lumbosacral Radicular Pain Associated With Disk Herniation
A Phase 1 study of Sciatica, sponsored by Cephalon.
- Completed
- Registry status
- Phase 1
- Development phase
- 98
- Enrollment target
- 20
- Study locations
NCT01240876: Completed Phase 1 study of Sciatica, sponsored by Cephalon.
NCT01240876 is a Phase 1 study of Sciatica that has completed, run by Cephalon. The registered enrollment target is 98 participants, above the 71-participant average among 6 other Sciatica trials with a reported enrollment target (38% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01240876, a Phase 1 study of Sciatica, has completed, sponsored by Cephalon.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 98 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the study is to evaluate the safety and efficacy of CEP-37247 compared with placebo as assessed by the occurrence of adverse events, and the mean change in average pain intensity (API) in the affected leg.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CEP-37247
Study Locations (20)
California
- Teva Investigational Site 22 - La Mesa
- Teva Investigational Site 18 - Laguna Hills
- Teva Investigational Site 19 - Pasadena
- Teva Investigational Site 2 - Pasadena
South Carolina
- Teva Investigational Site 1 - Greenville
- Teva Investigational Site 11 - North Charleston
- Teva Investigational Site 6 - Spartanburg
Florida
- Teva Investigational Site 14 - Orlando
- Teva Investigational Site 5 - Sarasota
Georgia
- Teva Investigational Site 10 - Marietta
- Teva Investigational Site 13 - Marietta
Utah
- Teva Investigational Site 4 - Orem
- Teva Investigational Site 3 - Salt Lake City
Illinois
- Teva Investigational Site 9 - Bloomington
Kansas
- Teva Investigational Site 15 - Overland Park
Louisiana
- Teva Investigational Site 8 - Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
What the finished NCT01240876 record still lists
NCT01240876 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, above the 71-participant average among 6 other Sciatica trials with a reported enrollment target (38% higher).
The record links to 1 condition, with Sciatica appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01240876 names 20 study sites across 12 states, led by California, South Carolina, Florida.
Frequently Asked Questions
What is clinical trial NCT01240876 about?
NCT01240876 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Placulumab (CEP-37247) Administered by the Transforaminal Epidural Route for the Treatment of Patients With Lumbosacral Radicular Pain Associated With Disk Herniation". The primary objective of the study is to evaluate the safety and efficacy of CEP-37247 compared with placebo as assessed by the occurrence of adverse events, and the mean change in average pain intensity (API) in the affected leg.
What is the current status of trial NCT01240876?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 98 participants. The study started on 2011-01. Estimated completion is 2013-04.
What conditions does trial NCT01240876 study?
This clinical trial studies the following conditions: Sciatica.
What interventions are being tested in trial NCT01240876?
The interventions under investigation include: Placebo (DRUG), CEP-37247 (DRUG).
Who is sponsoring clinical trial NCT01240876?
This trial is sponsored by Cephalon, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01240876 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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