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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00832663

First Posted: January 30, 2009

Last Update Posted: March 16, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

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

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 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

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:

Muscle regeneration [ Time Frame: 1 month ]

Secondary Outcome Measures:

Muscle strength [ Time Frame: 1 month ]


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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


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 Submitted:	January 29, 2009
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

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