Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT00752661
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
74 Years
Study:
NCT00752661
Study Brief:
Protocol Section:
NCT00752661