Patients With Grade II Ankle SprainPhase 3NCT01987570
Effect of Allopurinol Administration on the Prevention of Muscle Mass Loss in Subject Immobilized.
A Phase 3 study testing Allopurinol in people with Patients With Grade II Ankle Sprain, run by Instituto de Investigacion Sanitaria La Fe at 2 sites in Spain.
Trial summary
Generating critical levels of power is a prerequisite for performing simple daily activities, such as rising from a chair or climbing stairs. For a young healthy person these activities can be performed easily, however after a prolonged period of forced inactivity (such as during the recovery from a sports injury… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men only
- Conditions the study is for
- Patients With Grade II Ankle Sprain
- What is being tested?
- Allopurinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 2 sitesSpain
- Study dates
- Apr 2012to Jul 2016
- Phase
- Phase 3
- 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 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with grade II sprain.
- Boys
- Age 20-40 years.
- Patient without regular medication.
- All patients must provide written informed consent specific to this study complete.
Who cannot join
- Liver and gastrointestinal disease.
- Untreated hypothyroidism.
- Alcohol and / or drug addiction.
- Vitamin supplements.
- Eating Disorders.
- Drugs that decrease the concentration of lipids.
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- Antihypertensive drugs.
- Athletes who exercise intensely.
- Mental disorders, depression or anxiety intensive. These conditions make the patient unable to understand the nature or the scope and possible consequences of the study.
- Patients presenting an infectious process and / or inflammatory before collecting the sample.
- Patients may not follow the protocol because of its lack of cooperation, to their inability to return to subsequent visits and there is little chance of completing the study procedures.
- Hypersensitivity to allopurinol
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
University of Valencia
Valencia, Valencia, 46010
Hospital Universitari i Politècnic La Fe
Valencia, Valencia, 46026
About this study
Generating critical levels of power is a prerequisite for performing simple daily activities, such as rising from a chair or climbing stairs. For a young healthy person these activities can be performed easily, however after a prolonged period of forced inactivity (such as during the recovery from a sports injury, prolonged bed rest or spaceflight) a loss of muscle mass occurs. It has been suggested that this loss may be triggered by oxidative stress. An enzyme involved in the production of free radicals in various experimental models, including immobilization, is xanthine oxidase (XO). Although allopurinol is an inhibitor of XO widely used in clinical practice, its effect on the maintenance of muscle mass after an immobilization protocol is unknown. Thus, the major aim of this clinical trial is to determine the effect of allopurinol administration on the prevention of muscle mass loss in immobilized subjects.
This is a prospective, randomized study in which fifty young male subjects (aged between 25 and 40 years) diagnosed with grade II ankle sprain will be recruited. After immobilization the patients will be assigned randomly to one of two experimental groups, one treated with allopurinol (n=25) and the other with placebo (n=25). The dosage of allopurinol will be the same as recommended for gout patients, i.e. 300 mg/day orally, during all the immobilization period, which will last fifteen days. This medication will be delivered to the patients when they agree to participate in the clinical trial. They will be immobilized by posterior knee splint, preventing use of that leg.
We will determine muscle mass loss by performing two magnetic resonances of both legs before and after the immobilization period. We will also take two blood samples (before and after immobilization) to measure oxidative stress parameters (malondialdehyde, protein carbonyls, and XO activity), inflammatory parameters (IL-6, C-reactive protein and 1-antichymotrypsin), as well as vitamin D levels.
- Conditions
- Patients With Grade II Ankle Sprain
- Being tested
- Allopurinol, Placebo
- Keywords
- Xanthine oxidase, Magnetic resonance, Oxidative stress, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
Also called 1H-pirazolo (3,4-d)pirimidina-4-ol, Zyloric
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol | Experimental | One tablet of allopurinol is administrated orally at a dose of 300 mg/24 hours, during the time that the patient remains immobilized for 15 days. Receives: Drug: Allopurinol |
| Placebo | Placebo comparator | One tablet/24 hours of placebo orally, during the time that the patient remains immobilized for 15 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass loss
Checks the loss of muscle mass percentage with Magnetic Resonance before and after treatment.
Measured: Day 0 and day 15
The role of xanthine oxidase in the loss of muscle mass
Measure xanthine oxidase activity in plasma
Measured: Day 0 and day 15
Secondary outcomes (2)
size of the leg muscles in a group of immobilized subjects.
Checks the loss of muscle mass size with Magnetic Resonance before and after treatment.
Measured: Day 0 and day 15
oxidative stress parameters
Glutathione (GSH), glutathione disulfide (GSSG), malondialdehyde (MDA) and oxidized proteins, after a period of immobilization of 15 days duration.
Measured: Day 0 and day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startApr 2012
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Grade II Ankle SprainStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JOSÉ VIÑA, MD PhD (HON), Study director, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987570
- Sponsor's protocol ID
- ALMU_2011
- Other IDs
- 2011-003541-17
- Status last verified
- Jul 2015
- First submitted
- 12 Nov 2013
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Allopurinol Administration on the Prevention of Muscle Mass Loss in Subject Immobilized.
- ClinicalTrials.gov ID
- NCT01987570
- Acronym / sponsor ID
- ALMU_2011
- Conditions
- Patients With Grade II Ankle Sprain
- Keywords
- Xanthine oxidase, Magnetic resonance, Oxidative stress, Inflammation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 19 Nov 2013 (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.
Generating critical levels of power is a prerequisite for performing simple daily activities, such as rising from a chair or climbing stairs. For a young healthy person these activities can be performed easily, however after a prolonged period of forced inactivity (such as during the recovery from a sports injury, prolonged bed rest or spaceflight) a loss of muscle mass occurs. It has been suggested that this loss may be triggered by oxidative stress. An enzyme involved in the production of free radicals in various experimental models, including immobilization, is xanthine oxidase (XO). Although allopurinol is an inhibitor of XO widely used in clinical practice, its effect on the maintenance of muscle mass after an immobilization protocol is unknown. Thus, the major aim of this clinical trial is to determine the effect of allopurinol administration on the prevention of muscle mass loss in immobilized subjects.
This is a prospective, randomized study in which fifty young male subjects (aged between 25 and 40 years) diagnosed with grade II ankle sprain will be recruited. After immobilization the patients will be assigned randomly to one of two experimental groups, one treated with allopurinol (n=25) and the other with placebo (n=25). The dosage of allopurinol will be the same as recommended for gout patients, i.e. 300 mg/day orally, during all the immobilization period, which will last fifteen days. This medication will be delivered to the patients when they agree to participate in the clinical trial. They will be immobilized by posterior knee splint, preventing use of that leg.
We will determine muscle mass loss by performing two magnetic resonances of both legs before and after the immobilization period. We will also take two blood samples (before and after immobilization) to measure oxidative stress parameters (malondialdehyde, protein carbonyls, and XO activity), inflammatory parameters (IL-6, C-reactive protein and 1-antichymotrypsin), as well as vitamin D levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allopurinol | Experimental | Drug: AllopurinolOne tablet of allopurinol is administrated orally at a dose of 300 mg/24 hours, during the time that the patient remains immobilized for 15 days. |
| Placebo | Placebo comparator | Drug: PlaceboOne tablet/24 hours of placebo orally, during the time that the patient remains immobilized for 15 days. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with grade II sprain.
- Boys
- Age 20-40 years.
- Patient without regular medication.
- All patients must provide written informed consent specific to this study complete.
Key exclusion criteria (12 listed)
- Liver and gastrointestinal disease.
- Untreated hypothyroidism.
- Alcohol and / or drug addiction.
- Vitamin supplements.
- Eating Disorders.
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 |
|---|---|---|
| AllopurinolAlso: 1H-pirazolo (3,4-d)pirimidina-4-ol, Zyloric | Drug | Allopurinol |
| Placebo | Drug | Placebo |
Primary outcome
Muscle mass loss
Time frame: Day 0 and day 15
Checks the loss of muscle mass percentage with Magnetic Resonance before and after treatment.
The role of xanthine oxidase in the loss of muscle mass
Time frame: Day 0 and day 15
Measure xanthine oxidase activity in plasma
2 secondary outcomes
size of the leg muscles in a group of immobilized subjects.
Time frame: Day 0 and day 15
oxidative stress parameters
Time frame: Day 0 and day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
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.
JOSÉ VIÑA, MD PhD (HON) study director
University of Valencia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Allopurinol in people with Patients With Grade II Ankle Sprain, run by Instituto de Investigacion Sanitaria La Fe at 2 sites in Spain.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle mass loss (time frame: Day 0 and day 15). The study lists 2 primary outcomes in all. 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 8 Sep 2016.