An Efficacy and Safety Study of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen in Participants With Chronic Low-Back Pain
Information source: Janssen Korea, Ltd., Korea
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Low Back Pain
Intervention: Tramadol HCl/acetaminophen Extended Release (Drug); Placebo (Drug); Tramadol HCl/acetaminophen Extended Release (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Janssen Korea, Ltd., Korea Official(s) and/or principal investigator(s): Janssen Korea, Ltd. Clinical Trial, Study Director, Affiliation: Janssen Korea, Ltd.
Summary
The purpose of this study is to evaluate the efficacy and safety of extended release (ER)
tramadol hydrochloride (HCl)/acetaminophen compared with placebo in participants with
chronic (lasting a long time) low-back pain.
Clinical Details
Official title: A Randomized, Placebo-Controlled, Parallel Group, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Tramadol HCl/Acetaminophen Extended Release Tablet in Subjects With Chronic Low Back Pain
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Percentage of Participants With Reduction in Pain IntensityChange From Baseline in Pain Intensity at Day 29
Secondary outcome: Percentage of Participants With Pain ReliefChange From Baseline in Short Form (SF)-36 Score at Day 29 Change From Baseline in Oswestry Disability Index (ODI) Korean Version Score at Day 29 Percentage of Participants With Investigator's Global Assessment on Investigational Product Percentage of Participants With Participants' Global Assessment on Investigational Product
Detailed description:
This is a double blind (a medical research study in which neither the researchers nor the
participants know what treatment the participants is receiving), randomized (study drug is
assigned by chance), placebo-controlled, parallel group (a medical research study comparing
the response in 2 or more groups of participants receiving different interventions
[treatments]) and up-titration study in participants with chronic low back pain. The study
will consist of 6 visits (Day - 7 to Day -1 [Visit 1], Day 1 [Visit 2], Day 3 [telephone
visit], Day 8 [Visit 3], Day 15 [Visit 4] and Day 29 [Visit 5]) and 2 phases: a screening
phase and treatment phase. Screening phase will be of 7 days during which, participants will
receive stable dose of non-steroidal anti-inflammatory drugs (NSAIDS) or COX-2 selective
inhibitors (NSAID that specifically inhibits an enzyme known as cyclooxygenase-2) for pain
therapy. On the basis of average pain intensity over the last 48 hours which will be
measured at baseline (at the end of screening period), participants will enter the treatment
phase. Treatment phase will be of 28 days which includes 7-days of dose titration period. In
treatment phase all participants will be randomly assigned to 1 of 2 possible treatments:
tramadol HCl 75 milligram (mg)/acetaminophen 650 mg ER tablet treatment or the equivalent
placebo (an inactive substance) treatment until study completion, Day 29. Participants will
receive 1 tablet of tramadol HCl/acetaminophen ER or its equivalent placebo, once daily for
3 days. After the first 3 days, the participants will receive a telephone inquiry monitoring
the occurrence of adverse events and will be given additional administration instructions
for the next 4 days (1 tablet twice daily for 4 days). From Day 7, participants will receive
1 or 2 tablets twice a day depending on the degree of pain relief required. Participants
will visit the center on the Day 8 (Visit 3), Day 15 (Visit 4), and Day 29 (Visit 5) after
starting study drug. The efficacy will be assessed by measuring extent of reduction in pain
intensity on a Visual Analog Scale (VAS). Participants' safety will be monitored throughout
the study.
Eligibility
Minimum age: 25 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Participants diagnosed with low back pain at least 3 months before the screening or
washout period
- Participants who have taken a stable dose of Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs) (drugs used for reducing inflammation and pain ) or Cyclo-Oxygenase 2
(COX-2) selective inhibitors (an anti-inflammatory drug that fights pain) from 7 days
before investigational product administration, and could maintain the same dose
during the period of the study
- Participants whose average pain intensity is more than or equal to 4. 0 centimeters on
Visual Analog Scale over the last 48 hours after the completion of screening
- Postmenopausal or surgically sterile or abstinent women or practicing a highly
effective method of birth control
- Women with childbearing potential must have negative pregnancy test
Exclusion Criteria:
- Participants who have taken tramadol or tramadol HCl or acetaminophen, or narcotic
(strong habit-forming drug that stops pain and depresses the central nervous system)
analgesic tablet within 30 days before investigational product administration
- Participants who have taken acetaminophen tablet within 7 days before investigational
product administration
- Participants with tumor or infection in meninges or spinal cord
- Participants who have fibromyalgia (neurosensory disorder characterized by muscle
pain, joint stiffness, and fatigue), reflex sympathetic dystrophy (feeling of pain
associated with evidence of minor nerve injury) or causalgia (persistent, severe
burning sensation of the skin), acute spinal cord compression, acute nerve root
compression, severe lower extremity weakness or numbness, regional pain syndrome,
meningitis (inflammation of the meninges), diskitis (nonbacterial inflammation of an
intervertebral disk or disk space), back pain because of secondary infection or
tumor, or pain caused by a confirmed or suspected neoplasm
- Participants who have taken analgesic (including local agents or anesthetics),
sedative-hypnotic (e. g., diazepam), or muscle relaxant other than a stable dose of
NSAIDs or COX-2 selective inhibitors within 5 times the half-life of the concerned
agent before investigational product administration
Locations and Contacts
Additional Information
Starting date: May 2009
Last updated: June 20, 2013
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