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.

Completed · Phase 3

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID

NCT00347685

Run by

Bausch Health Americas, Inc.

People needed

650

Starts

2000-10-01

Expected to finish

2003-02-01

Last updated by the study team

2012-06-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Gainesville Clinical Research Center — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.