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Bioequivalence Between Integrated E-TRANS (Fentanyl) System and Separated (Two-Part) E-TRANS (Fentanyl) System

This study has been completed.
Sponsor:
Information provided by:
Alza Corporation, DE, USA
ClinicalTrials.gov Identifier:
NCT00990418
First received: October 2, 2009
Last updated: April 26, 2010
Last verified: April 2010
  Purpose

The purpose of this study is to confirm that the two forms of the device the Integrated E-TRANS (fentanyl HCl) system and the Separated (Two-Part) E-TRANS (fentanyl HCl) System provide the equivalent blood levels of medication (fentanyl HCL).


Condition Intervention Phase
Pain, Postoperative
Drug: Separated (Two Part) E-TRANS (fentanyl HCl) System; Integrated E-TRANS (fentanyl HCl) System
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioequivalence Between Integrated E-TRANS (Fentanyl) System and Separated (Two-Part) E-TRANS (Fentanyl) System

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Assessment of the bioequivalence of the Separated (Two-Part) E-TRANS (fentanyl HCl) System and the Integrated E-TRANS (fentanyl HCl) System [ Time Frame: 0 (predose), 0.5, 1.0, 2.0, 4.0, 6.0, 8.0, 10.0, 11.0, 12.5, 13.33, 13.5, 14.0, 15.0, 16.0, 18.0, 20.0, 24.0, 27.0, 30.0, 36.0, and 47.0 hours after initiation of treatment ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: March 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:

The objective of this study is to establish bioequivalence between the Integrated E-TRANS (fentanyl HCl) System and the Separated (Two-Part) E-TRANS (fentanyl HCl) System. The target indication is the short-term management of acute postoperative pain in adult patients requiring opioid analgesia during hospitalization. This is a single-center, open-label (all people involved know the identity of the intervention), randomized, 2-period, 2-treatment, 2-sequence, crossover (participants will receive different interventions sequentially during the study) interventions study. Each volunteer will be randomly assigned to a sequence. There will be a washout period of 6 to 14 days between treatments. Volunteers will remain at the study site during fentanyl treatments and for the 34 hours following completion of each treatment. Approximately 60 healthy volunteers will be enrolled to ensure that 40 volunteers have completed pharmacokinetic evaluations in both treatments. Each volunteer will receive both Treatment A and Treatment B (either Treatment A followed by Treatment B or Treatment B followed by Treatment A.) Treatment A is 80 consecutive doses of Ontegrated E-TRANS (fentanylHCL) 40mcg System, each delivered over 10 minutes for a total delivery time of over 13.33 hours. Treatment B is 80 consecutive doses of Separated (Two-Part) E-TRANS (fentanyl HCL) 40 mcg System, each delivered over 10 minutes, for a total deliver time of over 13.33 hours. Blood samples for pharmacokinetic analysis (analysis of the amount of drug in the blood at specific time points) will be collected from each volunteer during all fentanyl treatments and up to 34 hours after termination of each treatment. The skin site to which an E-TRANS (fentanyl HCl) System has been applied will be monitored for the development of topical (skin irritation) adverse events at 1 and 24 hours after removal of the system(s). Safety evaluations to be performed include adverse event monitoring, laboratory assessments, alcohol testing, serum pregnancy testing for women of child-bearing potential, urine drug screening, physical examination, electrocardiogram, continuous pulse oximetry to monitor oxygen saturation, respiratory rate, blood pressure, heart rate, respiratory rate, and temperature. The study will continue for up to approximately 3 weeks, including the washout periods of 6 to 14 days in between treatments, excluding the screening period. Treatment A: Integrated E-TRANS (fentanyl HCl) 40 mcg System 80 consecutive doses, each delivered over 10 minutes over 13.33 hours Treatment B: Separated (Two-Part) E-TRANS (fentanyl HCl) 40 mcg System 80 consecutive doses, each delivered over 10 minutes over 13.33 hours. Volunteers will be randomly assigned to either receive either Treatment A followed by Treatment B or Treatment B followed by Treatment A.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (of 18.0 to 28.0 kg/m2 at screening
  • Healthy based on medical history, physical examination, blood chemistry, blood count, urinalysis, and electrocardiogram
  • Blood pressure between 90 to 139 mmHg systolic (inclusive) and 50 to 89 mmHg diastolic (inclusive) after sitting for 5 minutes

Exclusion Criteria:

  • Evidence of clinically significant hepatic, reproductive, gastrointestinal, renal, hematologic, pulmonary, neurologic, respiratory, endocrine, or cardiovascular system abnormalities, psychiatric disorders or acute infection
  • Patients with confirmed screening QTc interval >450 msec or a history of additional risk factors for torsades de pointes, or the use of other medications that are currently being taken that prolong the QT/QTc interval (measure of electric conduction in the heart by ECG test)
  • Patients who have supine-to-standing blood pressure decrease of >20 mmHg systolic or >10 mmHg diastolic after standing for 3 minutes or have symptoms of lightheadedness, dizziness, or fainting upon standing
  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: NCT00990418

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

No publications provided

Responsible Party: Senior Director, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00990418     History of Changes
Other Study ID Numbers: CR013654
Study First Received: October 2, 2009
Last Updated: April 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Alza Corporation, DE, USA:
Postoperative pain
E-TRANS System, fentanyl HCl System
E-TRANSS (fentanyl HCl) System
Acute postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Fentanyl
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014