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Sponsored by: |
Massachusetts General Hospital |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00685295 |
Assess whether transbuccal fentanyl provides more rapid relief of orthopedic pain, than does the comparator Percocet
Condition | Intervention | Phase |
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Pain, Fracture, Sprain |
Drug: Fentanyl rapid dissolving tablet 100mcg Drug: lansoprazole 15mg rapidly dissolving tablet + Percocet PO |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain in the ED |
Estimated Enrollment: | 100 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
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Drug: Fentanyl rapid dissolving tablet 100mcg
Fentanyl rapid dissolving tablet 100mcg will be given
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2: Active Comparator
Subject receives Percocet swallowed pill, and Prevacid comparator rapidly dissolving transbuccal tablet
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Drug: lansoprazole 15mg rapidly dissolving tablet + Percocet PO
lansoprazole 15mg rapidly dissolving tablet + Percocet PO will be given
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion/Exclusion Criteria. The study population will comprise patients 18-60 years of age who present to the ED with a chief complaint of extremity injury, and who are triaged to the ED's "Minor Surgery" area. The trigger for evaluation for study eligibility will be the clinician-determined need for extremity radiography to rule-out fracture. To participate in the study, patients must meet the following inclusion and exclusion criteria:
Since the Prevacid SoluTab formulation to be used as the inactive placebo contains phenylalanine, subjects with phenylketonuria will be excluded from the study.
Responsible Party: | Stephen H. Thomas MD MPH ( Stephen H. Thomas MD MPH ) |
Study ID Numbers: | FAIRTOP |
Study First Received: | May 23, 2008 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00685295 |
Health Authority: | United States: Food and Drug Administration |
Emergency Department acute |
Fentanyl Fractures, Bone Emergencies Pain Lansoprazole |
Anesthetics, Intravenous Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Gastrointestinal Agents Central Nervous System Depressants Anesthetics Enzyme Inhibitors Narcotics Pharmacologic Actions |
Adjuvants, Anesthesia Sensory System Agents Anesthetics, General Therapeutic Uses Anti-Ulcer Agents Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |