![]() |
|
![]() |
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
Endo Pharmaceuticals |
Information provided by: | Endo Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00225797 |
The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone extended release in non-cancer patients with chronic low back pain.
Condition | Intervention | Phase |
Chronic Pain |
Drug: Oxymorphone Extended Release |
Phase III |
MedlinePlus related topics: | Back Pain |
ChemIDplus related topics: | Oxymorphone Oxymorphone hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Titration Followed by a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Tolerability, and Safety of Oxymorphone Extended Release Tablets in Opioid-Naïve Patients With Chronic Low Back Pain |
Estimated Enrollment: | 160 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | July 2005 |
Patients with low back pain who are sub-optimally responsive to their current analgesic treatment begin open-label treatment with oxymorphone extended release (ER). During the Open-Label Titration Period, patients will receive daily oxymorphone ER by mouth (PO) q12h. The investigator will initiate the Open-Label Titration Period using study drug at a dose of 5 mg PO q12h for 2 days; thereafter, patients will continue receiving 5 mg q12h or be titrated at increments of 5-10 mg q12h every 3-7 days until stabilization is achieved. The goal of the Open-Label Titration Period is to determine for each patient a fixed dose of study medication that is tolerated and achieves adequate analgesia. Stabilized patients will be randomiozed to either continue with current dose of oxymorphone ER or receive placebo for a total duration of 12 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
![]() |
Show 33 Study Locations |
Endo Pharmaceuticals |
Study ID Numbers: | EN3202-031 |
First Received: | September 22, 2005 |
Last Updated: | September 22, 2005 |
ClinicalTrials.gov Identifier: | NCT00225797 |
Health Authority: | United States: Food and Drug Administration |
|
|
|
|
![]() |