Muscle DamageNCT00832663
Influence of Non-steroidal Anti-inflammatory Drugs (NSAID) on Muscle Regeneration
A study testing NSAID in people with Muscle Damage, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage
- What is being tested?
- NSAID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2009to Dec 2009
- Phase
- Interventional
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- healthy
- does not exercise regularly
Who cannot join
- displays contraindications for taking NSAID
- well-trained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Blocking Inflammatory Activity in Vivo on Skeletal Muscle Regeneration in Humans
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.
Read the 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.
- Conditions
- Muscle Damage
- Being tested
- NSAID, placebo
- Keywords
- Muscle regeneration, Satellite cells, electrical stimulation, eccentric contractions, myogenic precursor cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSAIDDrug
Effect of NSAID ingestion on muscle regeneration
placeboDrug
receive placebo
| Study group | Role | What they receive |
|---|---|---|
| NSAID | Experimental | receive NSAID Receives: Drug: NSAID |
| Placebo | Placebo comparator | receive placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle regeneration
Measured: 1 month
Secondary outcomes (1)
Muscle strength
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation, Team Denmark, Danish Ministry of Culture, Anti Doping Danmark, The Danish Rheumatism Association, King Christian IX and Queen Louise Jubilee Bursary
- Investigators
- Abigail L Mackey, PhD, Principal investigator, Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832663
- Sponsor's protocol ID
- AM_P64_BBH
- Other IDs
- H-D-2008-074
- Status last verified
- Mar 2010
- First submitted
- 29 Jan 2009
- Last updated
- 16 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Blocking Inflammatory Activity in Vivo on Skeletal Muscle Regeneration in Humans
- ClinicalTrials.gov ID
- NCT00832663
- Acronym / sponsor ID
- AM_P64_BBH
- Conditions
- Muscle Damage
- Keywords
- Muscle regeneration, Satellite cells, electrical stimulation, eccentric contractions, myogenic precursor cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Lundbeck Foundation, Team Denmark, Danish Ministry of Culture, Anti Doping Danmark, The Danish Rheumatism Association, King Christian IX and Queen Louise Jubilee Bursary
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Jan 2009 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSAID | Experimental | Drug: NSAIDreceive NSAID |
| Placebo | Placebo comparator | Drug: placeboreceive placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male
- healthy
- does not exercise regularly
Key exclusion criteria (2 listed)
- displays contraindications for taking NSAID
- well-trained
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 |
|---|---|---|
| NSAIDEffect of NSAID ingestion on muscle regeneration | Drug | NSAID |
| placeboreceive placebo | Drug | Placebo |
Primary outcome
Muscle regeneration
Time frame: 1 month
1 secondary outcome
Muscle strength
Time frame: 1 month
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 16 Mar 2010.
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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.
Abigail L Mackey, PhD principal investigator
Institute of Sports Medicine Copenhagen, Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NSAID in people with Muscle Damage, run by Bispebjerg Hospital at 1 site in Denmark.
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 3 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: finished, as of the sponsor's last update on 16 Mar 2010. 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 Denmark. 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.
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 regeneration (time frame: 1 month). 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 2010.