- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00886002
Comparison of Two Dosage Strengths of Transdermal Fentanyl Versus Transdermal Buprenorphine and Placebo in Acute Pain Models in Healthy Volunteers.
Explorative, Double-blind Study on Dose Effectiveness of DUROGESIC D-Trans 12 Mcg/h and 25mcg/h Compared to Transtec and Placebo in Acute Pain Models in Healthy Volunteers.
Study Overview
Detailed Description
After having read and signed the written informed consent form, patients will participate in a screening visit (within 2 weeks before study start, see above selection of study participants). Patients will participate in a training session to experience the three pain test procedures and to assure whether they are able to perform the tests and they are willing to accept these stimuli during the study. They will be hospitalized for 4 treatment cycles (4 days / 5 nights each during which the 4 treatments mentioned under 'Purpose of the Study' are given). Between the hospitalizations they are not required to come to us. The new day -1 for the next cycle is at the same day of the week 2 weeks after the previous hospitalization. For each treatment cycle they enter the facility in the evening (day -1) before the patch is administered and may leave in the morning of day 5. Assessments will be made as follows:
Evening of Day -1: urine drug and alcohol screen, pregnancy test for females, interview by the study physician in charge Days 1, 2, 3, 4, and 5 in the morning: vital signs, pulsoximetry (assessment of oxygen saturation by means of a finger clip) From Day 1 in the morning to Day 5 in the morning: continuous ECG From Day 1 in the morning to Day 4 in the morning: patch administration on the back Days 1, 2, and 4 in the morning: three pain tests*, pupillometry (measurement of the pupil size by a photographic device), blood sample for the measurement of the drug plasma concentrations prior to patch administration in the morning of day 1 they perform three pain tests* (heat, cold pressure test, electric stimulation at the forearm) to assess baseline values and the skin will be checked at the designated patch locations. Patch adhesion will be checked regularly after administration. Patients will be asked regularly during your stay in the unit about concomitant medications and whether any adverse event occurred. In the morning of day 5, before dismission, a physical exam will be performed. The skin underneath the patch will be assessed after removal. After the fourth hospitalisation phase they will leave the facility and they have to return for an ambulant follow up visit 6 - 9 days thereafter. Vital signs will be recorded, they will be asked about concomitant medications and adverse events, a physical exam, clinical laboratory, vital signs and an electrocardiogram will be performed. After this visit the study is terminated. The electrical stimulation model uses a commercially available and registered for human use constant current device delivering wave pulses of 3-s duration. Two electrodes are applied to the lateral lower arm. To determine pain threshold an ascending staircase design is used starting with randomly varied stimuli. The intensity of the stimulus is increased until the pain threshold is reached and afterwards further increased until the maximally tolerated pain is reached. Once pain threshold and the maximally tolerated stimulus are identified, a series of stimuli evenly spaced between a stimulus 30% less than the pain threshold and the maximally tolerated stimulus is administered in a random fashion and the patient rates the pain on a visual analogue scale (VAS).
Heat test: A thermode will be applied on the forearm. The temperature of the thermode will be continuously increased from 30 C to a maximum of 56 C. They will be asked to give a signal when perceiving the heat as painful and to press the bottom when feeling the heat as intolerable pain and not wanting the heat to be further increased.
Cold pressor test: The left hand will be immersed in ice-saturated water for a maximum of 2 min. If pain is felt as intolerable before 2 min have elapsed, they can withdraw the hand. Perceived pain intensity will be rated continuously on a 10 mm visual analogue scale and recorded. Patients will receive one of four treatments one after another: transdermal fentanyl 25 mcg/h, transdermal fentanyl 12 mcg/h, transdermal buprenorphine 35 mcg/h,placebo. All of these treatments are administered as patches. Treatment duration per patch is 72 hours. After this time the patch is removed. Before the next patch of the following treatment will be applied, there will be 11 days without any drug administration. Total duration of the study is 56 days.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy on the basis of a pre-study physical examination
- Subjects who are willing to be hospitalized
- subjects who are willing and able to participate in the pain tests and show responsive pain pattern
Exclusion Criteria:
- History or presence of liver or renal insufficiency
- acute liver inflammation, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, haematologic, psychiatric or metabolic disturbances
- severe restriction of respiratory function
- treatment with MAO inhibitors during the last four weeks
- active skin disease or skin irritation at designated patch locations
- history of chronic pain (episodes of more than three months of chronic pain)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The first objective of the trial is to identify which acute pain model differentiates best between placebo and transdermal fentanyl 25µg/h.
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Secondary Outcome Measures
Outcome Measure |
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The second objective is to investigate, whether a significant dosage effect correlation exists in the target model between transdermal fentanyl 25µg/h, 12µg/h and placebo and TRANSTEC 35 mcg/h.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Janssen-Cilag A.G. Clinical Trial, Janssen-Cilag A.G.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Acute Pain
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Narcotic Antagonists
- Fentanyl
- Buprenorphine
- Naloxone
Other Study ID Numbers
- CR002443
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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