Conditions: Chronic Low Back Pain
Keywords: Back Pain Chronic Low Back Pain Chronic Back Pain Pain Chronic Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 459
Healthy volunteers: no

Brief summary:
This study will test an experimental drug called OROS® hydromorphone hydrochloride (HCl) (NMED-1077), a once daily opioid analgesic that can relieve pain. A large number of clinical studies have been conducted to test this drug. OROS hydromorphone HCl is currently approved in both the US and Europe to treat chronic pain.

The purpose of this study is to compare OROS hydromorphone to placebo to see if it is safe and efficacious.

Detailed description:

Arms:
arm 1: OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg arm 2: Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).

Interventions: intervention 1: OROS hydromorphone intervention 2: Placebo
Intervention descriptions: intervention 1: hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets intervention 2: Placebo

Protocol document: