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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00347685
First received: July 1, 2006
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Chronic Pain
Drug: tramadol ER
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

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

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

Estimated Enrollment: 650
Study Start Date: October 2000
Estimated Study Completion Date: February 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347685

Locations
United States, Florida
Gainesville Clinical Research Center
Gainesville, Florida, United States, 32605
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
  More Information

No publications provided

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00347685     History of Changes
Other Study ID Numbers: B00.CTOL.003.TRA P03
Study First Received: July 1, 2006
Last Updated: June 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Valeant Pharmaceuticals International, Inc.:
chronic non-malignant pain; chronic pain; non-malignant
pain; moderate pain; severe pain

Additional relevant MeSH terms:
Tramadol
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 29, 2014