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

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ClinicalTrials.gov Identifier: NCT00832663
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : March 16, 2010
Sponsor:
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

Study Description
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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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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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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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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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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
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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    Key Record Dates
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