NCT01845558

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 28, 2015

Status Verified

August 1, 2015

Enrollment Period

1.6 years

First QC Date

April 23, 2013

Last Update Submit

August 27, 2015

Conditions

Muscle InjuryMuscle SorenessExercise Induced Muscle Damage

Keywords

Muscle sorenessExercise induced muscle damageInflammationProteolytic enzymesMuscle strength Dynamometer

Outcome Measures

Primary Outcomes (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

    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.

    immediately before, 24h post, 48h post

Secondary Outcomes (5)

  • Maximal concentric strength (Nm) before and after the stress test

    immediately before, 0h, 3h, 6h, 24h, 48h, 72h

  • Pressure induced pain

    immediately before, 0h, 3h, 6h, 24h, 48h, 72h

  • Blood routine parameters

    immediately before, 0h, 3h, 6h, 24h, 48h, 72h

  • blood pressure

    immediately before, 24h, 48h, 72h

  • Movement induced pain

    immediately before, 0h, 3h, 6h, 24h, 48h, 72h post

Study Arms (2)

Wobenzym® plus

EXPERIMENTAL

Treatment with the licenced drug Wobenzym® plus (3x4 Capsules/ day)

Drug: Wobenzym® plus

Placebo equates Wobenzym® plus but without active ingredients

PLACEBO COMPARATOR

3x4 capsules/ day

Other: Placebo

Interventions

Wobenzym® plusDRUG
Wobenzym® plus
PlaceboOTHER
Placebo equates Wobenzym® plus but without active ingredients

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sportschule FFb Puch GmbH

Fürstenfeldbruck, 82256, Germany

Location

MeSH Terms

Conditions

MyalgiaInflammation

Interventions

Wobenzym

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Helmut Pabst, Dr. med

    PWC GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2013

First Posted

May 3, 2013

Study Start

February 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 28, 2015

Record last verified: 2015-08

Locations

DE(1)