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NCT00832663 Clinical Trial

Influence of Non-steroidal Anti-inflammatory Drugs (NSAID) on Muscle Regeneration

Muscle Damage Clinical Trial

Official title:
The Influence of Blocking Inflammatory Activity in Vivo on Skeletal Muscle Regeneration in Humans

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00832663
Other study ID # AM_P64_BBH
Secondary ID H-D-2008-074
Status Completed
Phase N/A
First received January 29, 2009
Last updated March 15, 2010
Start date April 2009
Est. completion date December 2009

Study information
Verified date March 2010
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- male

- healthy

- does not exercise regularly

Exclusion Criteria:

- displays contraindications for taking NSAID

- well-trained

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• NSAID
Effect of NSAID ingestion on muscle regeneration
• placebo
receive placebo

Locations
Country Name City State
Denmark Bispebjerg Hospital Copenhagen NV

Sponsors (7)
Lead Sponsor Collaborator
Bispebjerg Hospital Anti Doping Danmark, Danish Ministry of Culture, King Christian IX and Queen Louise Jubilee Bursary, Lundbeck Foundation, Team Denmark, The Danish Rheumatism Association

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Muscle regeneration 1 month No
Secondary Muscle strength 1 month No
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