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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Muscle Damage	Drug: NSAID; Drug: placebo	Not Applicable

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

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Study Type :	Interventional (Clinical Trial)
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 :	April 2009
Actual Primary Completion Date :	December 2009
Actual Study Completion Date :	December 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Muscle regeneration [ Time Frame: 1 month ]

Secondary Outcome Measures :

1. Muscle strength [ Time Frame: 1 month ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 35 Years (Adult)
Sexes 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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	January 30, 2009
Last Update Posted:	March 16, 2010
Last Verified:	March 2010

Keywords provided by Bispebjerg Hospital:

Muscle regeneration; Satellite cells; electrical stimulation; eccentric contractions; myogenic precursor cells

Additional relevant MeSH terms:

Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents	Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents