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

March 15, 2010 updated by: Bispebjerg Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • NV
      • Copenhagen, NV, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • male
  • healthy
  • does not exercise regularly

Exclusion Criteria:

  • displays contraindications for taking NSAID
  • well-trained

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Muscle regeneration
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Muscle strength
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

Lundbeck Foundation
The Danish Rheumatism Association
Team Denmark
Danish Ministry of Culture
Anti Doping Danmark
King Christian IX and Queen Louise Jubilee Bursary

Investigators

  • Principal Investigator: Abigail L Mackey, PhD, Institute of Sports Medicine copenhagen, Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

January 29, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (Estimate)

January 30, 2009

Study Record Updates

Last Update Posted (Estimate)

March 16, 2010

Last Update Submitted That Met QC Criteria

March 15, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AM_P64_BBH
  • H-D-2008-074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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