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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00347685
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : June 21, 2012
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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 treatment of chronic, non-malignant pain.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: tramadol ER Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 650 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Assessment of the Safety and Effectiveness of Extended Release Tramadol (Tramadol ER) in the Treatment of Chronic Non-malignant Pain.
Study Start Date : October 2000
Study Completion Date : February 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
Drug Information available for: Tramadol

Primary Outcome Measures :
  1. The primary outcomes are analyses of adverse events (incidence, frequency,
  2. severity, attribution, adverse events causing withdrawal from study)

Secondary Outcome Measures :
  1. The secondary outcomes are pain intensity (visual analog scale) assessment,
  2. patient global assessment of study medication, pain recall (least, worst and
  3. average pain); changes from baseline to each subsequent visit.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00347685

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United States, Florida
Gainesville Clinical Research Center
Gainesville, Florida, United States, 32605
Sponsors and Collaborators
Bausch Health Americas, Inc.

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Responsible Party: Bausch Health Americas, Inc. Identifier: NCT00347685     History of Changes
Other Study ID Numbers: B00.CTOL.003.TRA P03
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: June 21, 2012
Last Verified: June 2012

Keywords provided by Bausch Health Americas, Inc.:
chronic non-malignant pain; chronic pain; non-malignant
pain; moderate pain; severe pain

Additional relevant MeSH terms:
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Chronic Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents