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.

• Status: Completed
• Trial end date: 2003-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Tramadol

Criteria

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.