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
Information obtained from ClinicalTrials.gov on June 20, 2008
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 Corporation, DE, USA
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: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study
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
- Ilicit drug, prescription drug, or alcohol abuse
- Cardiopulmonary disease
- Pregnant or breastfeeding
Locations and Contacts
Additional Information
A study to evaluate the safety of D-TRANS fentanyl with naltrexone in adult patients with chronic pain and who are opioid tolerant
Starting date: January 2003
Ending date: July 2003
Last updated: March 28, 2008
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