Overview

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