A Study to Evaluate the Safety of D-TRANS Fentanyl With Naltrexone in Adult Patients With Chronic Pain and Who Are Opioid Tolerant

This study has been completed.
Sponsor:
Information provided by:
Alza Corporation, DE, USA
ClinicalTrials.gov Identifier:
NCT00650182
First received: March 28, 2008
Last updated: May 18, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Chronic Pain
Drug: fentanyl; naltrexone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety Evaluation of D-TRANS Fentanyl With Naltrexone HCL in Opioid Tolerant Patients (ALZA C-2002-022)

Resource links provided by NLM:


Further study details as provided by Alza Corporation, DE, USA:

Primary Outcome Measures:
  • 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 Measures:
  • 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.

Enrollment: 406
Study Start Date: January 2003
Study Completion Date: July 2003
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650182

Sponsors and Collaborators
Alza Corporation, DE, USA
Investigators
Study Director: Alza Corporation Clinical Trial ALZA
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00650182     History of Changes
Other Study ID Numbers: CR006715
Study First Received: March 28, 2008
Last Updated: May 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Alza Corporation, DE, USA:
patch
fentanyl
chronic pain

Additional relevant MeSH terms:
Naltrexone
Fentanyl
Analgesics, Opioid
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Central Nervous System Depressants
Analgesics
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on July 26, 2014