drugset / Trial / NCT00980798

Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee

NCT00980798

Phase 3 Completed 288 enrolled Janssen-Cilag International NV
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a once-daily formulation of a strong opioid against placebo in patients, who are suffering from pain due to osteoarthritis of the hip or the knee and who previously did not receive any strong opioids.The clinical trial tests the effect of the treatment on symptoms of pain, stiffness and physical function. The effect of the treatment on parameters on health related quality of life as well as quality of sleep will be measured.

Timeline

Start
2007-10
Primary completion
2008-11
Completion
2008-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydromorphone Other / unclassified 4 mg Oral
Subject Hydromorphone Other / unclassified 8 mg Oral
Subject Hydromorphone Other / unclassified 12 mg Oral
Subject Hydromorphone Other / unclassified 16 mg Oral
Subject Hydromorphone Other / unclassified 24 mg Oral
Subject Hydromorphone Other / unclassified 32 mg Oral