A Randomized, Double-Blind, Multiple-Dose Study to Assess the Ability of Cebranopadol to Suppress Withdrawal Signs and Symptoms in Adults With Chronic Pain Who Are Physically Dependent on Opioids
Adneuris Therapeutics, Inc.
Summary
This Phase 2 study will evaluate whether multiple doses of cebranopadol suppress opioid withdrawal signs and symptoms compared with placebo in adults with chronic pain who are physically dependent on prescribed opioids. Participants whose physical dependence is confirmed will be assigned by chance to one of two cebranopadol dose regimens or matching placebo. The study will also evaluate pain, safety and tolerability, and cebranopadol pharmacokinetics.
Description
Participants will complete outpatient screening followed by an inpatient treatment period and a safety follow-up telephone call. Within 30 days of initiating screening, participants will be admitted to the clinical research site. Their current prescribed opioid will be withheld after the scheduled morning dose on Day -1, and withdrawal signs and symptoms will be assessed using the Clinical Opiate Withdrawal Scale (COWS) and Subjective Opioid Withdrawal Scale (SOWS) to confirm physical dependence. Participants meeting the predefined withdrawal criteria will resume their prescribed opioid as sp…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Adults 18-65 years with BMI 18.0-40.0 kg/m² and weight ≥50 kg. * Chronic daily pain for ≥6 months due to chronic low back pain, hip/knee osteoarthritis, or painful peripheral neuropathy. * Prescribed opioid use ≥5 days/week for ≥3 months within the prior 6 months, generally 50-90 MME/day; \>90 MME/day may be allowed with Sponsor/designee approval. * Generally in good health and able to comply with study procedures, including opioid withdrawal and inpatient confinement. * Meet protocol-specified reproductive and contraception requirements. * Able to provide informed c…
Interventions
- DrugCebranopadol
Administration orally twice daily on Days 1 and 2 and according to the assigned regimen.
- DrugCebranopadol
Administration orally twice daily on Days 1 and 2 and according to the assigned regimen.
- DrugPlacebo
Administration orally twice daily on Day 1 and 2.
Locations (2)
- 001127North Canton, Ohio
- 00113Houston, Texas