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Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise (2012-005003-40)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01845558
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : August 28, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Muscle Injury Muscle Soreness Exercise Induced Muscle Damage Drug: Wobenzym® plus Other: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Wobenzym® Plus in Healthy, Sportive People After Eccentric Exercise - a Randomized, Two-stage, Double-blind, Placebo-controlled Cross-over Trial
Study Start Date : February 2013
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Wobenzym® plus
Treatment with the licenced drug Wobenzym® plus (3x4 Capsules/ day)
Drug: Wobenzym® plus
Placebo Comparator: Placebo equates Wobenzym® plus but without active ingredients
3x4 capsules/ day
Other: Placebo


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Maximal concentric strength (Nm) before and after the stress test [ Time Frame: immediately before, 0h, 3h, 6h, 24h, 48h, 72h ]
    Reduction of strength induced by the excentric stress test

  2. Pressure induced pain [ Time Frame: immediately before, 0h, 3h, 6h, 24h, 48h, 72h ]
    Pain induced by the stress test rated via Algometry kg/cm*cm induced by standardised pressure

  3. Blood routine parameters [ Time Frame: immediately before, 0h, 3h, 6h, 24h, 48h, 72h ]
    Blood routine parameters (differentiated haemogram; blood lipids; glucose; kreatinin) as safety parameters

  4. blood pressure [ Time Frame: immediately before, 24h, 48h, 72h ]
    Blood pressure and heart rate as safety parameter

  5. Movement induced pain [ Time Frame: immediately before, 0h, 3h, 6h, 24h, 48h, 72h post ]
    Pain induced by a standardised movement and rated by the volunteer via VAS.


Eligibility Criteria

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845558


Locations
Germany
Sportschule FFb Puch GmbH
Fürstenfeld Bruck, Germany, 82256
Sponsors and Collaborators
Mucos Pharma GmbH & Co. KG
Investigators
Principal Investigator: Helmut Pabst, Dr. med PWC GmbH
More Information

Responsible Party: Mucos Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT01845558     History of Changes
Other Study ID Numbers: BTS651/12
2012-005003-40 ( EudraCT Number )
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015

Keywords provided by Mucos Pharma GmbH & Co. KG:
Muscle soreness
Exercise induced muscle damage
Inflammation
Proteolytic enzymes
Muscle strength Dynamometer

Additional relevant MeSH terms:
Myalgia
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Wobenzym
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs