Muscular FatiguePhase 4NCT00785811
Effect of Chronic Supplementation of L-arginine in the Muscular Performance
A Phase 4 study testing L-arginine aspartate (Targifor) in people with Muscular Fatigue, run by Sanofi at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscular Fatigue
- What is being tested?
- L-arginine aspartate (Targifor)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2008to Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Muscular Fatigue
- Being tested
- L-arginine aspartate (Targifor), Placebo L-arginine aspartate (Targifor)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-arginine aspartate (Targifor)Drug
3g of L-arginine taken orally in a single daily dose for 8 weeks
Placebo L-arginine aspartate (Targifor)Drug
Placebo of L-arginine taken orally in a single daily dose for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | L-arginine aspartate (Targifor) Receives: Drug: L-arginine aspartate (Targifor) |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo L-arginine aspartate (Targifor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Resistance Factor (FRF)
Measured: Throughout the study
Secondary outcomes (3)
Maximum force in Newton (N) and fast or explosive force
Measured: at time 30% of the maximum isometric force
Maximum force in Newton (N) and fast or explosive force
Measured: at time 50% of the maximum isometric force
Maximum force in Newton (N) and fast or explosive force
Measured: at time 90% of the maximum isometric force
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Required by the investigator. The site could not recruit patients anymore.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular FatigueStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jaderson Lima, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785811
- Sponsor's protocol ID
- LARAS_L_02921
- Status last verified
- Mar 2011
- First submitted
- 4 Nov 2008
- Last updated
- 16 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00785811
- Acronym / sponsor ID
- LARAS_L_02921
- Conditions
- Muscular Fatigue
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Required by the investigator. The site could not recruit patients anymore.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: L-arginine aspartate (Targifor)L-arginine aspartate (Targifor) |
| 2 | Placebo comparator | Drug: Placebo L-arginine aspartate (Targifor)Placebo |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-arginine aspartate (Targifor)3g of L-arginine taken orally in a single daily dose for 8 weeks | Drug | 1 |
| Placebo L-arginine aspartate (Targifor)Placebo of L-arginine taken orally in a single daily dose for 8 weeks | Drug | 2 |
Primary outcome
Fatigue Resistance Factor (FRF)
Time frame: Throughout the study
3 secondary outcomes
Maximum force in Newton (N) and fast or explosive force
Time frame: at time 30% of the maximum isometric force
Maximum force in Newton (N) and fast or explosive force
Time frame: at time 50% of the maximum isometric force
Maximum force in Newton (N) and fast or explosive force
Time frame: at time 90% of the maximum isometric force
Results and safety
The study was stopped early (reason given: Required by the investigator. The site could not recruit patients anymore.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaderson Lima study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing L-arginine aspartate (Targifor) in people with Muscular Fatigue, run by Sanofi at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Required by the investigator. The site could not recruit patients anymore.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Resistance Factor (FRF) (time frame: Throughout the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2011.