Status:
COMPLETED
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.
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Immediate release (IR) tramadol has demonstrated efficacy in several pain conditions including: obstetrical, gynecological, orthopedic, abdominal, and oral surgery. The short elimination half-life of ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
End Date :
February 1 2003
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT00347685
Start Date
October 1 2000
End Date
February 1 2003
Last Update
June 21 2012
Active Locations (1)
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1
Gainesville Clinical Research Center
Gainesville, Florida, United States, 32605