- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00347685
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.
June 20, 2012 updated by: Bausch Health Americas, Inc.
Open-label Assessment of the Safety and Effectiveness of Extended Release Tramadol (Tramadol ER) in the Treatment of Chronic Non-malignant Pain.
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 Overview
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 IR tramadol necessitates every 4-6 hour dosing to maintain optimum levels of analgesia in chronic pain.
The study medication in this study is a once-daily, extended release (ER) tramadol formulation.
This study is a multicenter, multiple-dose, 1-year open-label study designed to assess the safety and effectiveness of tramadol HCl ER.
Patients with moderate to severe chronic non-malignant pain, requiring treatment with an analgesic on a daily basis, are eligible for study participation.
Patients eligible for enrollment are as follows: those who completed 12 weeks in one of two prior double-blind studies ("roll-over patients") or those without participation in any prior study of tramadol HCl ER ("direct enrollment patients").
Following a screening evaluation and baseline assessment, roll-over patients will be treated for up to 38 weeks and direct enrollment patients for up to 58 weeks.
At baseline (Visit 2), patients will receive tramadol HCl ER 100 mg once daily (QD) for 3 days; on day 4, they will increase to tramadol HCl ER 200 mg QD, based on tolerability.
Patients will be required to be on a minimum dose of tramadol HCl ER 200 mg QD by Visit 3. At Visit 4, patients are required to begin treatment with a minimum dose of tramadol HCl ER 300 mg QD.
The maximum dose of tramadol HCl ER for patients >= 75 years old is 300 mg QD.
By Visit 5, patients < 75 years old are to be initiated on a tramadol HCl ER dose of 400 mg QD.
Patients who cannot tolerate a dose increase of tramadol HCl ER from 300 mg or 400 mg QD (due to side effects) or who upon dose increase cannot tolerate the dose will be permitted to reduce the tramadol HCl ER dose to 300 mg QD.
Patients unable to tolerate tramadol HCl ER 300 mg or 400 mg QD or those who had pain unresponsive to appropriate dose adjustments will be discontinued and alternate analgesic therapy initiated, as appropriate.
Study Type
Interventional
Enrollment
650
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Gainesville, Florida, United States, 32605
- Gainesville Clinical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary outcomes are analyses of adverse events (incidence, frequency,
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severity, attribution, adverse events causing withdrawal from study)
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Secondary Outcome Measures
Outcome Measure |
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The secondary outcomes are pain intensity (visual analog scale) assessment,
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patient global assessment of study medication, pain recall (least, worst and
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average pain); changes from baseline to each subsequent visit.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2000
Study Completion
February 1, 2003
Study Registration Dates
First Submitted
July 1, 2006
First Submitted That Met QC Criteria
July 1, 2006
First Posted (Estimate)
July 4, 2006
Study Record Updates
Last Update Posted (Estimate)
June 21, 2012
Last Update Submitted That Met QC Criteria
June 20, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B00.CTOL.003.TRA P03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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