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

This study has been terminated.
(Required by the investigator. The site could not recruit patients anymore.)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00785811
First received: November 4, 2008
Last updated: March 15, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Muscular Fatigue
 Drug: L-arginine aspartate (Targifor)
Drug: Placebo L-arginine aspartate (Targifor)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Randomized, Double Blind, Placebo Controlled Study of Parallel Groups to Evaluate the Effect of Chronic Supplementation of L-arginine in the Muscular Performance.

Resource links provided by NLM:

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Fatigue Resistance Factor (FRF) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum force in Newton (N) and fast or explosive force [ Time Frame: at time 30% of the maximum isometric force ] [ Designated as safety issue: No ]
  • Maximum force in Newton (N) and fast or explosive force [ Time Frame: at time 50% of the maximum isometric force ] [ Designated as safety issue: No ]
  • Maximum force in Newton (N) and fast or explosive force [ Time Frame: at time 90% of the maximum isometric force ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: October 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
L-arginine aspartate (Targifor)
 Drug: L-arginine aspartate (Targifor)
3g of L-arginine taken orally in a single daily dose for 8 weeks
Placebo Comparator: 2
Placebo
 Drug: Placebo L-arginine aspartate (Targifor)
Placebo of L-arginine taken orally in a single daily dose for 8 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785811

Locations
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00785811     History of Changes
Other Study ID Numbers: LARAS_L_02921
Study First Received: November 4, 2008
Last Updated: March 15, 2011
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
N-Methylaspartate
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013