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Methodological Issues in Conducting Pilot Trials in Chronic Pain as Randomized, Double-blind, Placebo-controlled
Y Tominaga1, H Koga1, N Uchida1
1Janssen Japan, Tokyo, Japan.
Drug Research
|May 26, 2016
Summary
Tapentadol extended release (ER) failed to show efficacy over placebo in two small Japanese phase 2 studies for chronic pain. Methodological issues likely contributed to these findings.
Area of Science:
- Pharmacology
- Pain Management
- Clinical Trials
Background:
- Tapentadol ER is approved for chronic pain (osteoarthritis, low back pain, diabetic peripheral neuropathy) based on large phase 3 trials.
- Two pilot phase 2 studies were conducted in Japan to evaluate tapentadol ER for chronic pain.
- These Japanese studies were smaller and exploratory compared to prior registration trials.
Purpose of the Study:
- To assess the efficacy of tapentadol ER in Japanese patients with chronic pain.
- To compare tapentadol ER against placebo in managing osteoarthritis/low back pain and neuropathic pain.
Main Methods:
- Two randomized, double-blind, placebo-controlled phase 2 studies.
- 12-week treatment duration with tapentadol ER (25-250 mg) or placebo.
- Patients randomized in a 2:1 ratio (tapentadol ER:placebo).
Main Results:
- Neither study demonstrated a statistically significant difference between tapentadol ER and placebo for pain reduction.
- Concomitant analgesic use exceeded 80% in both studies.
- Tapentadol ER was generally well-tolerated by participants.
Conclusions:
- Methodological limitations, including small sample sizes and mixed patient populations, may have impacted study outcomes.
- The use of concomitant analgesics and potential placebo effects were noted as contributing factors.
- Further investigation may be needed to clarify tapentadol ER's role in specific chronic pain conditions in this population.
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