Effect of Chronic Supplementation of L-arginine in the Mu... | NCT00785811

Studies
Effect of Chronic Supplementation of L-arginine in the Muscular Performance

NCT00785811

Sponsor

Sanofi

Status

Terminated

Last Update Posted

Mar 16, 2011Estimated

Enrollment

36Actual

Phase

Phase 4

Conditions

Muscular Fatigue

Interventions

L-arginine aspartate (Targifor)
Placebo L-arginine aspartate (Targifor)

Countries

Brazil

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

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Required by the investigator. The site could not recruit patients anymore.

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Nov 4, 2008

First Submission Date that Met QC Criteria

Nov 4, 2008

First Posted Date

Nov 5, 2008Estimated

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, 2011

Last Update Posted Date

Mar 16, 2011Estimated

Description Module

Brief Summary

The primary purpose of this study is to evaluate the effect of oral administration of L-arginine in the muscular fatigue of the quadriceps, expressed in terms of the Fatigue Resistance Factor (FRF). The secondary purpose of this study is to evaluate the effect of oral administration of L-arginine in the muscular force the quadriceps.

Detailed Description

Not provided

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	L-arginine aspartate (Targifor)	Drug: L-arginine aspartate (Targifor)
2	Placebo Comparator	Placebo	Drug: Placebo L-arginine aspartate (Targifor)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
L-arginine aspartate (Targifor)	Drug	3g of L-arginine taken orally in a single daily dose for 8 weeks	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fatigue Resistance Factor (FRF)		Throughout the study

Secondary Outcomes

Measure	Description	Time Frame
Maximum force in Newton (N) and fast or explosive force		at time 30% of the maximum isometric force
Maximum force in Newton (N) and fast or explosive force		at time 50% of the maximum isometric force

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Healthy young adults for both sex; Age between 20 and 55 years; Slight or moderate physical activity, 30 minutes per day, at least 3 times a week;

Exclusion criteria:

Cardiac or pulmonary disease; Previous history of knee surgery or skeletal muscular dysfunctions in hip, knee or ankle joints; Athletic person (intensive anaerobic activity); None practiced of physical activity regularly; Medications usage

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jaderson Lima	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		São Paulo			Brazil