Influence of Non-steroidal Anti-inflammatory Drugs (NSAID) on Muscle Regeneration
This study has been completed.
Sponsor:
Bispebjerg Hospital
Collaborators:
Lundbeck Foundation
Team Denmark
Danish Ministry of Culture
Anti Doping Danmark
The Danish Rheumatism Association
King Christian IX and Queen Louise Jubilee Bursary
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00832663
First received: January 29, 2009
Last updated: March 15, 2010
Last verified: March 2010
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Purpose
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 | Intervention |
|---|---|
|
Muscle Damage |
Drug: NSAID Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | The Influence of Blocking Inflammatory Activity in Vivo on Skeletal Muscle Regeneration in Humans |
Further study details as provided by Bispebjerg Hospital:
Primary Outcome Measures:
- Muscle regeneration [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Muscle strength [ Time Frame: 1 month ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | April 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: NSAID
receive NSAID
|
Drug: NSAID
Effect of NSAID ingestion on muscle regeneration
|
|
Placebo Comparator: Placebo
receive placebo
|
Drug: placebo
receive placebo
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- male
- healthy
- does not exercise regularly
Exclusion Criteria:
- displays contraindications for taking NSAID
- well-trained
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832663
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832663
Locations
| Denmark | |
| 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 |
More Information
No publications provided
| Responsible Party: | Abigail Mackey, Institute of Sports Medicine Copenhagen |
| ClinicalTrials.gov Identifier: | NCT00832663 History of Changes |
| Other Study ID Numbers: | AM_P64_BBH, H-D-2008-074 |
| Study First Received: | January 29, 2009 |
| Last Updated: | March 15, 2010 |
| Health Authority: | Denmark: National Board of Health |
Keywords provided by Bispebjerg Hospital:
|
Muscle regeneration Satellite cells electrical stimulation |
eccentric contractions muscle regeneration myogenic precursor cells |
Additional relevant MeSH terms:
|
Anti-Inflammatory Agents, Non-Steroidal Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents |
Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015