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Sponsored by: |
Cumberland Pharmaceuticals |
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Information provided by: | Cumberland Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00470600 |
The primary objective of this study of Amelior administered to post-operative hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine the efficacy of Amelior compared to placebo for the treatment of post-operative pain by patients self-assessment of pain.
Condition | Intervention | Phase |
---|---|---|
Pain |
Drug: Amelior |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 140 |
Study Start Date: | May 2007 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator |
Drug: Amelior
800mg or placebo, IV
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2: Experimental |
Drug: Amelior
800mg or placebo, IV
|
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Wilmax Clinical Research Inc. | |
Mobile, Alabama, United States, 336608 | |
United States, Arkansas | |
Teton Research, LLC | |
Little Rock, Arkansas, United States, 72205 | |
United States, California | |
Clinical Management Services, Inc. | |
Arcadia, California, United States, 91007 | |
United States, Georgia | |
Southeastern Center for Clinical Trials | |
Atlanta, Georgia, United States, 30350 | |
United States, Texas | |
Research Concepts, Inc. | |
Houston, Texas, United States, 77401 | |
Research Concepts, Inc | |
Houston, Texas, United States, 77054 | |
South Africa | |
Eugene Marais Hospital | |
Pretoria, South Africa | |
Krugersdorp Private Hospital | |
Krugersdorp, South Africa | |
Johannesburg General Hospital | |
Johannesburg, South Africa |
Responsible Party: | Cumberland Pharmaceuticals Inc. ( Army Rock, Ph.D., Senior Manager, Regulatory Affairs ) |
Study ID Numbers: | CPI-CL-008C |
Study First Received: | May 7, 2007 |
Last Updated: | September 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00470600 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pain |