Influence of Non-steroidal Anti-inflammatory Drugs (NSAID... | NCT00832663

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

NCT00832663

Sponsor

Bispebjerg Hospital

Status

Completed

Last Update Posted

Mar 16, 2010Estimated

Enrollment

32Actual

Phase

Not Applicable

Conditions

Muscle Damage

Interventions

NSAID
placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
H-D-2008-074

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jan 29, 2009

First Submission Date that Met QC Criteria

Jan 29, 2009

First Posted Date

Jan 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2010

Last Update Posted Date

Mar 16, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Bispebjerg HospitalOTHER

Collaborators

Name	Class
Lundbeck Foundation	OTHER
Team Denmark	OTHER
Danish Ministry of Culture	UNKNOWN
Anti Doping Danmark

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NSAID	Experimental	receive NSAID	Drug: NSAID
Placebo	Placebo Comparator	receive placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NSAID	Drug	Effect of NSAID ingestion on muscle regeneration	NSAID

Measure	Description	Time Frame
Muscle regeneration		1 month

Measure	Description	Time Frame
Muscle strength		1 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male
healthy
does not exercise regularly

Exclusion Criteria:

displays contraindications for taking NSAID
well-trained

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abigail L Mackey, PhD	Institute of Sports Medicine Copenhagen, Bispebjerg Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bispebjerg Hospital		Copenhagen	NV	2400	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D000894	Anti-Inflammatory Agents, Non-Steroidal

Ancestor Terms

ID	Term
D018712	Analgesics, Non-Narcotic
D000700	Analgesics
D018689	Sensory System Agents
D018373	Peripheral Nervous System Agents

Browse Leaves

Not provided

Browse Branches

Not provided