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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00832663
First received: January 29, 2009
Last updated: March 15, 2010
Last verified: March 2010
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 24, 2014