Clinical trial
A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic…
NCT00472303 · Grünenthal GmbH, Industry · Completed
Key facts
| NCT number | NCT00472303 |
|---|---|
| Title | A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine |
| Official title | A Randomized Withdrawal, Active- and Placebo-controlled, Double-blind, Multi-center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 (Tapentadol) PR* in Subjects With Moderate to Severe Chronic Malignant Tumor-related Pain |
| Lead sponsor | Grünenthal GmbH, Industry |
| Collaborators | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Tumor, Pain |
| Intervention type | Drug |
| Interventions | Tapentadol Extended Release, Matching Placebo after Tapentadol in the Titration Phase., Morphine Sulphate Controlled Release |
| Enrollment | 622 |
| Start date | Jul 1, 2007 |
| Primary completion | Jun 1, 2012 |
| Completion | Jun 1, 2012 |
| First posted | May 11, 2007 |
| Last update posted | Nov 4, 2019 |
| Countries | Austria, Bulgaria, Croatia, Czechia, France, Germany, Hungary, Italy, Moldova, Poland, Romania, Russia and 4 more |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: