WobenzymPhase 2NCT02088411
The Safety and Efficacy of an Enzyme Combination in Managing Knee Osteoarthritis Pain in Adults
A Phase 2 study testing Diclofenac and Wobenzym in people with Wobenzym and Osteoarthritis, run by Atrium Innovations at 1 site in Germany.
Trial summary
The aim of this randomized, double-blind, placebo-controlled, comparator-controlled trial was to evaluate the safety and efficacy of an enzyme combination, as Wobenzym®, in adults with moderate-to-severe osteoarthritis (OA) of the knee. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Wobenzym, Osteoarthritis
- What is being tested?
- Diclofenac and Wobenzym
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2000to Nov 2001
- Phase
- Phase 2
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee osteoarthritis confirmed by radiography or tomography
- Lequesne Functional Index score of 10-14
- WOMAC-A pain subscale score greater than or equal to 25
Who cannot join
- History of knee trauma
- History of joint infection
- History of joint surgery
- History of intra-articular injection (viscotherapy)
- History of gastrointestinal diseases
- Use of corticosteroids
Show all 11Show fewer
- Use of COX-II inhibitors
- Use of glucosamine/chondroitin
- Known sensitivity to paracetamol
- Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)
- Known sensitivity to oral enzymes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Efficacy of an Enzyme Combination in Managing Knee Osteoarthritis Pain in Adults: a Randomized, Double-blind, Placebo-controlled Trial.
The aim of this randomized, double-blind, placebo-controlled, comparator-controlled trial was to evaluate the safety and efficacy of an enzyme combination, as Wobenzym®, in adults with moderate-to-severe osteoarthritis (OA) of the knee.
- Conditions
- Wobenzym, Osteoarthritis
- Being tested
- Diclofenac, Wobenzym, Placebo
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
WobenzymDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac | Active comparator | Subjects assigned to receive 1 tablet of Diclofenac Sodium (50 mg) and two tablets of an indistinguishable placebo three times daily for a duration of 12 weeks. Receives: Drug: Diclofenac |
| Wobenzym | Active comparator | Subjects assigned to receive 2 tablets of Wobenzym(R) and 1 tablet of an indistinguishable placebo three times daily for a duration of 12 weeks. Receives: Dietary Supplement: Wobenzym |
| Placebo | Placebo comparator | Subjects assigned to receive three tablets of an indistinguishable placebo three times daily for a duration of 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lequesne Functional Index
Self-assessment of the affected knee joint by physician interview using the Lequesne Functional Index (providing an estimate of the degree of pain associated with the affected joint, the maximum distance talked, and activities of daily living).
Measured: Change from baseline to 12 weeks
Secondary outcomes (6)
Western Ontario and McMaster Universities Index version 3.0 subscale for pain (WOMAC-A)
Measured: Change from baseline to 12 weeks
Western Ontario and McMaster Universities Index version 3.0 subscale for joint stiffness (WOMAC-B)
Measured: Change from baseline to 12 weeks
Western Ontario and McMaster Universities Index version 3.0 subscale for joint function (WOMAC-C)
Measured: Change from baseline to 12 weeks
Paracetamol Consumption
Number of paracetamol tablets consumed during the study by subjects
Measured: Change from baseline to 12 weeks
Indices of systemic inflammation
Erythrocyte sedimentation rates at 1 and 2 hours and serum concentration of C-reactive protein
Measured: Change from baseline to 12 weeks
Adverse Events
Any complications throughout study.
Measured: Through baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startNov 2000
- Primary completionNov 2001
- Study completionNov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WobenzymStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atrium Innovations
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mucos Pharma GmbH, Oberhaching, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088411
- Sponsor's protocol ID
- MU-699412
- Status last verified
- Mar 2014
- First submitted
- 13 Mar 2014
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of an Enzyme Combination in Managing Knee Osteoarthritis Pain in Adults: a Randomized, Double-blind, Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT02088411
- Acronym / sponsor ID
- MU-699412
- Conditions
- Wobenzym, Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Atrium InnovationsIndustry (pharma, biotech, devices)
- Collaborators
- Mucos Pharma GmbH, Oberhaching, Germany
- Study start
- Nov 2000
- Primary completion
- Nov 2001 (actual)
- Study completion
- Nov 2001 (actual)
- First posted
- 17 Mar 2014 (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 this randomized, double-blind, placebo-controlled, comparator-controlled trial was to evaluate the safety and efficacy of an enzyme combination, as Wobenzym®, in adults with moderate-to-severe osteoarthritis (OA) of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diclofenac | Active comparator | Drug: DiclofenacSubjects assigned to receive 1 tablet of Diclofenac Sodium (50 mg) and two tablets of an indistinguishable placebo three times daily for a duration of 12 weeks. |
| Wobenzym | Active comparator | Dietary Supplement: WobenzymSubjects assigned to receive 2 tablets of Wobenzym(R) and 1 tablet of an indistinguishable placebo three times daily for a duration of 12 weeks. |
| Placebo | Placebo comparator | Other: PlaceboSubjects assigned to receive three tablets of an indistinguishable placebo three times daily for a duration of 12 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Knee osteoarthritis confirmed by radiography or tomography
- Lequesne Functional Index score of 10-14
- WOMAC-A pain subscale score greater than or equal to 25
Key exclusion criteria (11 listed)
- History of knee trauma
- History of joint infection
- History of joint surgery
- History of intra-articular injection (viscotherapy)
- History of gastrointestinal diseases
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 |
|---|---|---|
| Diclofenac | Drug | Diclofenac |
| Wobenzym | Dietary supplement | Wobenzym |
| Placebo | Other | Placebo |
Primary outcome
Lequesne Functional Index
Time frame: Change from baseline to 12 weeks
Self-assessment of the affected knee joint by physician interview using the Lequesne Functional Index (providing an estimate of the degree of pain associated with the affected joint, the maximum distance talked, and activities of daily living).
6 secondary outcomes
Western Ontario and McMaster Universities Index version 3.0 subscale for pain (WOMAC-A)
Time frame: Change from baseline to 12 weeks
Western Ontario and McMaster Universities Index version 3.0 subscale for joint stiffness (WOMAC-B)
Time frame: Change from baseline to 12 weeks
Western Ontario and McMaster Universities Index version 3.0 subscale for joint function (WOMAC-C)
Time frame: Change from baseline to 12 weeks
Paracetamol Consumption
Time frame: Change from baseline to 12 weeks
Indices of systemic inflammation
Time frame: Change from baseline to 12 weeks
Adverse Events
Time frame: Through baseline to 12 weeks
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 17 Mar 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diclofenac and Wobenzym in people with Wobenzym and Osteoarthritis, run by Atrium Innovations 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 3 inclusion and 11 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 17 Mar 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Lequesne Functional Index (time frame: Change from baseline to 12 weeks). 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 17 Mar 2014.