A Study to Evaluate the Safety of D-TRANS Fentanyl With Naltrexone in Adult Patients With Chronic Pain and Who Are Opioid Tolerant
CompletedPhase 2NCT00650182
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The primary objective was to evaluate the safety of D-TRANS fentanyl with naltrexone HCl system compared to the Duragesic (fentanyl transdermal system) in opioid tolerant patients.
Study details
- Official title
- Safety Evaluation of D-TRANS Fentanyl With Naltrexone HCL in Opioid Tolerant Patients (ALZA C-2002-022)
- Conditions
- Interventions
- Drug: fentanyl
- naltrexone
- Sponsor
- Alza Corporation, DE, USA
- Start date
- 2003-01
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Diagnosis of chronic pain who require continuous opioid analgesia * Must enter the study on a stable dose of Duragesic for at least 21 days and consent to use a medically acceptable method of contraception throughout the entire study, and for females 1 week after the study is completed and for males 3 months after the study is completed. Exclusion Criteria: * Skin disease that precluded the use of a transdermal system * Clinically significant laboratory abnormalities * Significant mental status changes that result in disorientation, memory impairment, or inability to report accurately * Illicit drug, prescription drug, or alcohol abuse * Cardiopulmonary disease * Pregnant or breastfeeding.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00650182