A Study Comparing the Effectiveness and Safety of Extended-release Tramadol Versus Placebo in the Treatment of Chronic Low Back Pain

This study has been completed.
Sponsor:
Information provided by:
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT00347724
First received: July 2, 2006
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to compare the analgesic efficacy of oral, once-daily tramadol ER 300 mg and 200 mg to placebo in patients with moderate to severe chronic low back pain requiring daily analgesic treatment. The study hypothesis is that tramadol ER is effective in the treatment of moderate to severe chronic low back pain.


Condition Intervention Phase
Chronic Pain
Drug: Tramadol HCl ER
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Placebo-controlled, Parallel Group Comparison of the Efficacy and Safety of Extended Release Tramadol (Tramadol ER) 300 mg and 200 mg to Placebo in the Treatment of Chronic Low Back Pain

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Patient's pain intensity score since the previous visit,using a visual analog scale(VAS) where 0 mm = no pain and 100 mm = extreme pain.

Secondary Outcome Measures:
  • Patient's current pain intensity VAS score
  • Patient's global assessment
  • Roland Disability Index
  • Patient's sleep assessment

Estimated Enrollment: 600
Study Start Date: November 2000
Estimated Study Completion Date: November 2001
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 in order 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 is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study. At the Screening Visit, patients eligible for study participation by medical history, physical exam and other evaluations will enter a 2-7 day washout period during which time analgesics will not be allowed. At Visit 2, patients with a pain intensity >= 40 mm on a 100 mm visual analog scale (VAS) and who meet all other eligibility criteria will be admitted into a 3-week, open-label, run-in period during which time they will receive tramadol ER 100 mg once daily (QD) for at least 3 days. On Day 4, the dose will be increased to tramadol ER 200 mg QD, based on tolerability. Patients must be maintained on a minimum dose of tramadol 200 mg QD by the beginning of Week-2 (Visit 3); the dose may be increased to tramadol ER 300 mg QD at Visit 3, based on tolerability. Patients must increase their tramadol ER dose to 300 QD by the beginning of Week - 1 (Visit 4); this dose must be maintained for one week. Patients with pain unresponsive to appropriate dose adjustments or with unacceptable side effects will be discontinued from the study and an alternative analgesic therapy will be initiated. Patients receiving tramadol ER 300 mg QD at the end of the run-in period (Visit 5, Week 0) will enter a 12-week, double-blind period during which they will be randomized to receive tramadol ER 300 mg, tramadol ER 200 mg, or placebo QD. No dose adjustments will be permitted during the double-blind period of the study. Patients will return for safety and efficacy evaluations at Weeks 1, 2, 4, 8 and 12 or early termination. Study medication will be discontinued at Week 12 and patients will return after one week for a post-treatment visit (Week 13).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a history of chronic low back pain >= 6 months requiring treatment with NSAIDs, acetaminophen, opioid analgesics, COX-2 selective inhibitors, and/or muscle relaxants for at least 60 of the 90 days preceeding the screening visit; in good health as determined by the investigator on the basis of medical history, physical exam and screening labs; patient's low back pain intensity measures >= 40 mm on a visual analog scale (VAS) at the start of the run-in peroid after the 2-7 day washout; patients who are able to discontinue treatment with NSAIDs, COX-2 selective inhibitors, tramadol, muscle relaxants, opioids, and/or other analgesics during the 2-7 day washout period and all other analgesics throughout the entire study.

Exclusion Criteria:

  • Patients with a diagnosis of a complex regional pain syndrome, significant inflammatory pain, or clinically significant active fibromyalgia; patients with a history of lumbar surgery or chemonucleolysis; patients undergoing transcutaneous electrical nerve stimulation (TENS) or spinal manipulation for low back pain; patients with an uncontrolled medical condition or a clinically significant condition that would, in the investigator's opinion, preclude study participation; patients using analgesics or other agents during washout that could confound the analgesic response.
  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.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00347724     History of Changes
Other Study ID Numbers: B00.CT3.014.TRA P03
Study First Received: July 2, 2006
Last Updated: June 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Valeant Pharmaceuticals International, Inc.:
chronic low back pain; chronic pain; low back pain; extended-release analgesia; opioid

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Tramadol
Analgesics, Opioid
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

ClinicalTrials.gov processed this record on July 31, 2014