Phase 3
Completed N=1,117
A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain
Osteoarthritis, Hip · Osteoarthritis, Knee · Lower Back Pain · Postoperative Pain
Source: ClinicalTrials.gov NCT00361504 ↗
Enrolled (actual)
1,117
Serious AEs
5.2%
Results posted
Sep 2009
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (TEAE) — 766; 202 Participants
Summary
The purpose of this study is to evaluate the safety profile of tapentadol (CG5503) PR at doses of 100 mg - 250 mg administered twice daily over a maximum one year period to patients with at least a 3-month history of low back pain, or pain caused by knee or hip osteoarthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAE) |
766; 202 | — |
| SECONDARY Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS) |
-3.22; -3.14 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of knee or hip osteoarthritis with history of pain at the reference joint for at least 3 months or clinical diagnosis of low back pain of benign origin for at least 3 months
- Must be dissatisfied with their current analgesic therapy (e.g. Non-steroidal anti-inflammatory drugs NSAIDS, COX-2 inhibitors, opioids, paracetamol/acetaminophen
- Have a pain intensity >4 on Numerical Rating Scale
Exclusion Criteria
- Life-long history of seizure disorder or epilepsy
- Any of the following within one year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, and brain neoplasm
- Severe traumatic brain injury within 15 years (consisting of more than one of the following: brain contusion (injuries resulting in hemorrhage), intracranial hematoma, unconsciousness or post traumatic amnesia lasting for more than 24 hours) or residual sequelae suggesting transient changes in consciousness
- History of malignancy within past 2 years, with exception of a successfully treated basal cell carcinoma
- Presence of significant pain associated with conditions other than osteoarthritis or low back pain that could confound the assessment or self-evaluation of pain
Data sourced from ClinicalTrials.gov (NCT00361504). 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.