A One-year, Open-label Study to Assess the Safety and Effectiveness of Extended Release Tramadol HCl in the Treatment of Chronic, Non-malignant Pain.
CompletedPhase 3NCT00347685
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The purpose of this study is to assess the safety of tramadol HCl ER following long-term treatment. The study hypothesis is that long-term treatment with tramadol HCl ER is safe and effective for the treatment of chronic, non-malignant pain.
Study details
- Official title
- Open-label Assessment of the Safety and Effectiveness of Extended Release Tramadol (Tramadol ER) in the Treatment of Chronic Non-malignant Pain.
- Conditions
- Interventions
- Drug: tramadol ER
- Sponsor
- Bausch Health Americas, Inc.
- Start date
- 2000-10
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patients with a history of chronic, non-malignant pain \>= 6 months requiring treatment with an analgesic; females of childbearing potential practicing abstinence or a medically accepted form of contraception with a negative serum pregnancy test within 7 days of study entry; patients able to understand the procedures, complete the pain scales and able to communicate meaningfully with study personnel; patients who agree to study participation and sign a form indicating their informed consent. Exclusion Criteria: * Patients with an uncontrolled medical condition; patients whose weight \<= 100 pounds; patients with dysphagia or difficulty swallowing tablets; patients with intractable nausea and vomiting; patients with a history of clinically significant intolerance to tramadol or a known hypersensitivity to opioid analgesics, such that treatment with tramadol or other opioids is contraindicated.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00347685