Phase 3
Completed N=248
An Efficacy and Safety Study of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen in Participants With Chronic Low-Back Pain
Source: ClinicalTrials.gov NCT01112267 ↗Enrolled (actual)
248
Serious AEs
0.4%
Results posted
Jul 2013
Primary outcomePrimary: Percentage of Participants With Reduction in Pain Intensity — 57.65; 41.11 Percentage of Participants — p=0.0367
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Reduction in Pain Intensity |
57.65; 41.11 | 0.0367 sig |
| PRIMARY Change From Baseline in Pain Intensity at Day 29 |
6.334; 6.000; 2.299; 1.549 | 0.0095 sig |
| SECONDARY Percentage of Participants With Pain Relief |
70.73; 53.41; 82.35; 65.17; 81.18; 77.53 | 0.0202 sig |
| SECONDARY Change From Baseline in Short Form (SF)-36 Score at Day 29 |
46.71; 47.94; 9.82; 6.67; 44.93; 49.51 | 0.3524 |
| SECONDARY Change From Baseline in Oswestry Disability Index (ODI) Korean Version Score at Day 29 |
39.626; 38.126; 11.216; 7.178 | 0.0527 |
| SECONDARY Percentage of Participants With Investigator's Global Assessment on Investigational Product |
81.25; 69.88 | 0.0917 |
| SECONDARY Percentage of Participants With Participants' Global Assessment on Investigational Product |
76.25; 72.29 | 0.5632 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01112267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.