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| Sponsored by: |
Neuromed Pharmaceuticals |
|---|---|
| Information provided by: | Neuromed Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00631319 |
Purpose
To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) Pain
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Pain |
Drug: OROS HYDROMORPHONE |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase III, Flexible Dose Titration Followed by a Randomized Double-Blind Study of Controlled Release OROS Hydromorphone HCL Compared to Placebo in Patients With Chronic OA Pain |
| Estimated Enrollment: | 400 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Neuromed Pharmaceuticals ( Neuromed Pharmaceuticals ) |
| Study ID Numbers: | NMT 1077-302 |
| Study First Received: | February 28, 2008 |
| Last Updated: | February 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00631319 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
OA Chronic Pain Osteoarthritis OA Pain Osteoarthritis Pain |
Pain Hip Pain Knee Pain Joint Pain |
|
Hydromorphone Osteoarthritis Central Nervous System Depressants Narcotics Pain |
Peripheral Nervous System Agents Analgesics Arthralgia Analgesics, Opioid Acetaminophen |
|
Hydromorphone Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |