Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Pozen |
---|---|
Information provided by: | Pozen |
ClinicalTrials.gov Identifier: | NCT00433732 |
To determine the efficacy of the Trexima versus placebo as assessed by pain relief and the incidences of photophobia, phonophobia and nausea at 2 hours after treatment as the primary endpoints.
Condition | Intervention | Phase |
---|---|---|
Migraine Headaches |
Drug: sumatriptan Drug: naproxen sodium |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Multicenter, Randomized, Placebo-Controlled Single Dose Study to Evaluate the Safety and Efficacy Opf Trexima in the Acute Treatment of Migraine Headaches |
Estimated Enrollment: | 1400 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | April 2005 |
The primary objective of this study is to determine the efficacy of the Trexima versus placebo as assessed by pain relief and the incidences of photophobia, phonophobia and nausea at 2 hours after treatment as the primary endpoints. Another objective of this study is to evaluate the efficacy of Trexima when compared to the individual components (sumatriptan and naproxen sodium) using sustained pain-free as the endpoint. It is the intent that this study be sufficiently powered to detect differences that are clinically meaningful and statistically significant in order to meet both objectives.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A subject will be eligible for inclusion in this study if all of the following criteria apply:
Subject is a male or a female who is not pregnant or is not lactating. A female is eligible to enter and participate in this study if she is of
Child-bearing potential, has a negative pregnancy test (urine or serum) at screen, and employs one of the following acceptable measures of contraception:
Exclusion Criteria:
A subject will not be eligible for this study if any one or more of the following criteria apply:
United States, Arkansas | |
Little Rock Family Practice Clinic | |
Little Rock, Arkansas, United States, 72205 | |
United States, North Carolina | |
Pozen, Inc. | |
Chapel Hill, North Carolina, United States, 27517 |
Study Director: | David Taylor | Pozen, Inc. |
Study ID Numbers: | MT400-302 |
Study First Received: | February 8, 2007 |
Last Updated: | February 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00433732 History of Changes |
Health Authority: | United States: Food and Drug Administration |
TREXIMA MIGRAINE HEADACHES Subjects may be enrolled if they are 18-65 years of age, have a demonstrated history of migraine headaches |
Serotonin Agonists Anti-Inflammatory Agents Neurotransmitter Agents Naproxen Cyclooxygenase Inhibitors Central Nervous System Diseases Pain Headache Disorders, Primary Cardiovascular Agents Brain Diseases Serotonin Headache Disorders |
Sumatriptan Signs and Symptoms Analgesics, Non-Narcotic Migraine Disorders Headache Vasoconstrictor Agents Neurologic Manifestations Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
Serotonin Agonists Anti-Inflammatory Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Headache Disorders, Primary Pain Brain Diseases Gout Suppressants Headache Disorders Signs and Symptoms Migraine Disorders Sensory System Agents Therapeutic Uses Headache |
Vasoconstrictor Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics Naproxen Nervous System Diseases Cyclooxygenase Inhibitors Central Nervous System Diseases Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions Sumatriptan Serotonin Agents Analgesics, Non-Narcotic Neurologic Manifestations Peripheral Nervous System Agents |