Status:
COMPLETED
An Exploratory Study of Tramadol Hydrochloride in Patients With Osteoarthritis of the Knee or Low Back Pain
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Osteoarthritis
Low Back Pain
Eligibility:
All Genders
20-74 years
Phase:
PHASE2
Brief 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 no...
Detailed Description
Since JNS013 is a combination of tramadol hydrochloride (TRAM) acting as a weak opioid with acetaminophen (APAP) inhibiting central COX-3, it is expected to have an intermediate effect between narcoti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT00752661
Start Date
June 1 2007
End Date
November 1 2007
Last Update
May 17 2011
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