Muscle InjuryPhase 42012-005003-40NCT01845558
Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise
A Phase 4 study testing Wobenzym® plus in people with Muscle Injury and Muscle Soreness, run by Mucos Pharma GmbH & Co. KG at 1 site in Germany.
Trial summary
The aim of the current study is to investigate the therapeutic effect and especially the mode of action of Wobenzym® plus, an anti-inflammatory drug containing proteolytic enzymes, on exercise induced muscle damage (eiMD) and recovery time in male amateur sportsmen with medium proficiency level compared to placebo. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Injury, Muscle Soreness, Exercise Induced Muscle Damage
- What is being tested?
- Wobenzym® plus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2013to Sep 2014
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology
- Not anticipating any planned changes in lifestyle regarding activity and nutrition for the duration of the study
- Non smoker
- Men with strength training experience
- Age: 20-50 years
- BMI ≥20 kg/m2 and ≤ 32 kg/m2
- medium concentric strength ability (150-300 Nm)
Who cannot join
- Relevant history or presence of any medical disorder, potentially interfering with this trial (e.g. volunteers having experienced any cardiovascular events such as infarction, angina, surgical endocoronary intervention, stroke or volunteers suffering from diabetes as well as acute or chronic injury of the musculoskeletal system, e.g. cruciate ligament rupture.
- No intake of anti-inflammatory medication/ food supplements or intake of medications that directly affect parameters of muscle function or performance within 4 weeks prior to visit 1 or during the trial
- Subjects not willing to abstain from intake of analgesic medication 24 hours prior to and during visit 1 and 2.
- For this trial clinically relevant abnormal laboratory, vital signs or physical findings at screening
- Known hypersensitivity to the study preparation or to single ingredients (e.g. Lactose intolerance)
- Drug, alcohol and/or medication abuse
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- Known HIV-infection
- Known acute or chronic hepatitis B and C infection
- Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
- Blood donation within 4 weeks prior to trial start (visit 1) or during trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise - a Randomized, Two-stage, Double-blind, Placebo-controlled Cross-over Trial
The aim of the current study is to investigate the therapeutic effect and especially the mode of action of Wobenzym® plus, an anti-inflammatory drug containing proteolytic enzymes, on exercise induced muscle damage (eiMD) and recovery time in male amateur sportsmen with medium proficiency level compared to placebo.
- Being tested
- Wobenzym® plus, Placebo
- Keywords
- Muscle soreness, Exercise induced muscle damage, Inflammation, Proteolytic enzymes, Muscle strength Dynamometer
- Medical subject headings
- Myalgia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wobenzym® plusDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Wobenzym® plus | Experimental | Treatment with the licenced drug Wobenzym® plus (3x4 Capsules/ day) Receives: Drug: Wobenzym® plus |
| Placebo equates Wobenzym® plus but without active ingredients | Placebo comparator | 3x4 capsules/ day Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of maximal concentric strength, movement induced pain and pressure induced pain combined in a multidimensional (composite outcome)model giving information about the change induced by the stress test
Multidimensional approach for recovery and acute phase after eccentric stress test. Will be assessed at different time points before and after an excentric stress test and the reduction of these parameters under treatment will be calculated.
Measured: immediately before, 24h post, 48h post
Secondary outcomes (5)
Maximal concentric strength (Nm) before and after the stress test
Reduction of strength induced by the excentric stress test
Measured: immediately before, 0h, 3h, 6h, 24h, 48h, 72h
Pressure induced pain
Pain induced by the stress test rated via Algometry kg/cm*cm induced by standardised pressure
Measured: immediately before, 0h, 3h, 6h, 24h, 48h, 72h
Blood routine parameters
Blood routine parameters (differentiated haemogram; blood lipids; glucose; kreatinin) as safety parameters
Measured: immediately before, 0h, 3h, 6h, 24h, 48h, 72h
blood pressure
Blood pressure and heart rate as safety parameter
Measured: immediately before, 24h, 48h, 72h
Movement induced pain
Pain induced by a standardised movement and rated by the volunteer via VAS.
Measured: immediately before, 0h, 3h, 6h, 24h, 48h, 72h post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle InjuryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mucos Pharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helmut Pabst, Dr. med, Principal investigator, PWC GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845558
- Sponsor's protocol ID
- BTS651/12
- Other IDs
- 2012-005003-40
- Acronym
- 2012-005003-40
- Status last verified
- Aug 2015
- First submitted
- 23 Apr 2013
- Last updated
- 28 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise - a Randomized, Two-stage, Double-blind, Placebo-controlled Cross-over Trial
- ClinicalTrials.gov ID
- NCT01845558
- Acronym / sponsor ID
- 2012-005003-40 / BTS651/12
- Keywords
- Muscle soreness, Exercise induced muscle damage, Inflammation, Proteolytic enzymes, Muscle strength Dynamometer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Mucos Pharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 May 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.
The aim of the current study is to investigate the therapeutic effect and especially the mode of action of Wobenzym® plus, an anti-inflammatory drug containing proteolytic enzymes, on exercise induced muscle damage (eiMD) and recovery time in male amateur sportsmen with medium proficiency level compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wobenzym® plus | Experimental | Drug: Wobenzym® plusTreatment with the licenced drug Wobenzym® plus (3x4 Capsules/ day) |
| Placebo equates Wobenzym® plus but without active ingredients | Placebo comparator | Other: Placebo3x4 capsules/ day |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, haematology
- Not anticipating any planned changes in lifestyle regarding activity and nutrition for the duration of the study
- Non smoker
- Men with strength training experience
Key exclusion criteria (10 listed)
- Relevant history or presence of any medical disorder, potentially interfering with this trial (e.g. volunteers having experienced any cardiovascular events such as infarction, angina, surgical endocoronary intervention, stroke or volunteers suffering from diabetes as well as acute or chronic injury of the musculoskeletal system, e.g. cruciate ligament rupture.
- No intake of anti-inflammatory medication/ food supplements or intake of medications that directly affect parameters of muscle function or performance within 4 weeks prior to visit 1 or during the trial
- Subjects not willing to abstain from intake of analgesic medication 24 hours prior to and during visit 1 and 2.
- For this trial clinically relevant abnormal laboratory, vital signs or physical findings at screening
- Known hypersensitivity to the study preparation or to single ingredients (e.g. Lactose intolerance)
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 |
|---|---|---|
| Wobenzym® plus | Drug | Wobenzym® plus |
| Placebo | Other | Placebo equates Wobenzym® plus but without active ingredients |
Primary outcome
Reduction of maximal concentric strength, movement induced pain and pressure induced pain combined in a multidimensional (composite outcome)model giving information about the change induced by the stress test
Time frame: immediately before, 24h post, 48h post
Multidimensional approach for recovery and acute phase after eccentric stress test. Will be assessed at different time points before and after an excentric stress test and the reduction of these parameters under treatment will be calculated.
5 secondary outcomes
Maximal concentric strength (Nm) before and after the stress test
Time frame: immediately before, 0h, 3h, 6h, 24h, 48h, 72h
Pressure induced pain
Time frame: immediately before, 0h, 3h, 6h, 24h, 48h, 72h
Blood routine parameters
Time frame: immediately before, 0h, 3h, 6h, 24h, 48h, 72h
blood pressure
Time frame: immediately before, 24h, 48h, 72h
Movement induced pain
Time frame: immediately before, 0h, 3h, 6h, 24h, 48h, 72h post
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 28 Aug 2015.
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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.
Helmut Pabst, Dr. med principal investigator
PWC GmbH
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 Wobenzym® plus in people with Muscle Injury and Muscle Soreness, run by Mucos Pharma GmbH & Co. KG at 1 site in Germany.
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 8 inclusion and 10 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 28 Aug 2015. 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 Germany. 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 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?
Reduction of maximal concentric strength, movement induced pain and pressure induced pain combined in a multidimensional (composite outcome)model giving information about the change induced by the stress test (time frame: immediately before, 24h post, 48h post). 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 28 Aug 2015.