Influence of Non-steroidal Anti-inflammatory Drugs (NSAID) on Muscle Regeneration
Sponsor
Bispebjerg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00832663
Collaborator
Lundbeck Foundation (Other), Team Denmark (Other), Danish Ministry of Culture (Other), Anti Doping Danmark (Other), The Danish Rheumatism Association (Other), King Christian IX and Queen Louise Jubilee Bursary (Other)
32
1
2
8
4
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the influence of non-steroidal anti-inflammatory drugs (NSAIDs) on muscle regeneration.
The investigators' hypothesis is that ingestion of NSAID will delay or impair muscle regeneration.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The model employed to induce muscle damage is electrical stimulation. Muscle biopsies will be examined to follow the response of satellite cells and muscle regeneration. Study participants will be randomly assigned to a placebo or NSAID group in a double-blinded manner.
Study Design
Study Type:
Interventional
Actual Enrollment
:
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
The Influence of Blocking Inflammatory Activity in Vivo on Skeletal Muscle Regeneration in Humans
Study Start Date
:
Apr 1, 2009
Actual Primary Completion Date
:
Dec 1, 2009
Actual Study Completion Date
:
Dec 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NSAID receive NSAID |
Drug: NSAID
Effect of NSAID ingestion on muscle regeneration
|
| Placebo Comparator: Placebo receive placebo |
Drug: placebo
receive placebo
|
Outcome Measures
Primary Outcome Measures
- Muscle regeneration [1 month]
Secondary Outcome Measures
- Muscle strength [1 month]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 35 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
male
-
healthy
-
does not exercise regularly
Exclusion Criteria:
-
displays contraindications for taking NSAID
-
well-trained
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bispebjerg Hospital | Copenhagen | NV | Denmark | 2400 |
Sponsors and Collaborators
- Bispebjerg Hospital
- Lundbeck Foundation
- Team Denmark
- Danish Ministry of Culture
- Anti Doping Danmark
- The Danish Rheumatism Association
- King Christian IX and Queen Louise Jubilee Bursary
Investigators
- Principal Investigator: Abigail L Mackey, PhD, Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00832663
Other Study ID Numbers:
- AM_P64_BBH
- H-D-2008-074
First Posted:
Jan 30, 2009
Last Update Posted:
Mar 16, 2010
Last Verified:
Mar 1, 2010
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