An Exploratory Study of Tramadol Hydrochloride in Patients With Osteoarthritis of the Knee or Low Back Pain

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find the clinical dose range of an active ingredient of JNS013 - Tramadol hydrochloride in chronic-pain patients who cannot attain a sufficient analgesic effect from non-steroidal anti-inflammatory drugs (NSAIDs).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Tramadol

Criteria

Inclusion Criteria:

• Patients with chronic pain due to OA of the knee or LBP that persists for more than 3 months at the initiation of the observation period

• Patients who received oral NSAIDs at a usual highest dose for at least 14 consecutive days during 3 months before the initiation of the observation period, but could not attain a sufficient analgesic effect

• Patients with the intensity of the strongest pain during 48 hours before the initiation of the observation period is >= 40 mm and < 80 mm on VAS

• Ambulatory outpatients

• Prior to the conduct of the study, patients who were given a sufficient explanation about the investigational product and this study and have given their own consent in writing to participate in the study.

Exclusion Criteria:

• Patients with conditions for which opioids are contraindicated

• Patients with a hypersensitivity to opioids

• Patients who received TRAM in the past and discontinued the treatment due to ineffectiveness or adverse reactions

• Patients with complications associated with pain to the degree considered to have an influence on the efficacy assessment (trauma such as fracture, headache, post-herpetic neuralgia)

• Patients with a complication of severe spinal disease