A Study to Evaluate the Safety of D-TRANS Fentanyl With Naltrexone in Adult Patients With Chronic Pain and Who Are Opioid Tolerant
Information source: Alza Corporation, DE, USA
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Pain
Intervention: fentanyl; naltrexone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Alza Corporation, DE, USA Official(s) and/or principal investigator(s): Alza Corporation Clinical Trial, Study Director, Affiliation: ALZA
Summary
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.
Clinical Details
Official title: Safety Evaluation of D-TRANS Fentanyl With Naltrexone HCL in Opioid Tolerant Patients (ALZA C-2002-022)
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: To assess the safety of 2 transdermal formulations of fentanyl (D-TRANS fentanyl with naltrexone transdermal system and Duragesic (fentanyl transdermal system) in patients with chronic pain who were opioid tolerant.
Secondary outcome: Efficacy assessments included patient global assessments, investigator global assessments, pain intensity, and brief pain inventory. Blood samples were also to be collected for analysis of naltrexone and fentanyl prior to any dose change.
Detailed description:
This was a multicenter, randomized, double-blind, double-dummy safety study in adult
patients who required continuous opioid treatment for chronic pain. Patients had to be on a
stable dose of duragesic for 21 days prior to the start of the study treatment period and
have completed a screening period of at least 14 days to enter this study. Eligible patients
were randomized (2: 1) to receive the equivalent strength of D-TRANS fentanyl with naltrexone
HCl (and placebo Duragesic) or the same dose of Duragesic (and placebo D-TRANS fentanyl with
naltrexone HCl [D-TRANS fentanyl with naltrexone]) for a 15-day treatment period. If
necessary, patients could be titrated to higher or lower doses during the 15-day treatment
period. Each system was worn for 72 hours then replaced by a new system until the end of the
15-day treatment period. Patients were telephoned 3 times a day during the first 3 days of
the study and then once daily for the remainder of the study to determine if there were any
signs of opiate overdose or withdrawal. The patient was to be followed as medically
indicated based on the responses to the questions. Safety assessments included summarizing
the incidences of adverse events (including topical adverse events), vital signs
measurements, and clinical laboratory evaluations. Blood samples were also collected for
analysis of naltrexone and fentanyl concentrations at scheduled times during the study.
Efficacy assessments included patient global assessments, investigator global assessments,
pain intensity, and brief pain inventory. Blood samples were also to be collected for
analysis of naltrexone and fentanyl prior to any dose change and if a patient experienced a
serious adverse event possibly or probably related to study drug. Duragesic delivering
fentanyl doses of 25 mcg/h, 50 mcg/h, 75 mcg/h, or 100 mcg/h, and a D-TRANS placebo on Days
1, 4, 7, 10, and 13 or D-TRANS fentanyl with naltrexone delivering fentanyl doses of 25
mcg/h, 50 mcg/h, 75 mcg/h, or 100 mcg/h, and a placebo.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Click here to view the journal abstract from the study manuscript.
Starting date: January 2003
Last updated: May 18, 2011
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