NCT00832663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 16, 2010

Status Verified

March 1, 2010

Enrollment Period

8 months

First QC Date

January 29, 2009

Last Update Submit

March 15, 2010

Conditions

Muscle Damage

Keywords

Muscle regenerationSatellite cellselectrical stimulationeccentric contractionsmyogenic precursor cells

Outcome Measures

Primary Outcomes (1)

  • Muscle regeneration

    1 month

Secondary Outcomes (1)

  • Muscle strength

    1 month

Study Arms (2)

NSAID

EXPERIMENTAL

receive NSAID

Drug: NSAID

Placebo

PLACEBO COMPARATOR

receive placebo

Drug: placebo

Interventions

NSAIDDRUG

Effect of NSAID ingestion on muscle regeneration

NSAID
placeboDRUG

receive placebo

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • healthy
  • does not exercise regularly

You may not qualify if:

  • displays contraindications for taking NSAID
  • well-trained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, NV, 2400, Denmark

Location

MeSH Terms

Interventions

Anti-Inflammatory Agents, Non-Steroidal

Intervention Hierarchy (Ancestors)

Analgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic Agents

Study Officials

  • Abigail L Mackey, PhD

    Institute of Sports Medicine Copenhagen, Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 16, 2010

Record last verified: 2010-03

Locations

DK(1)