Knee OsteoarthritisPhase 2/3NCT00974428
Multi-Center Study Evaluating the Efficacy of Wobenzym(R)N in Treating Knee Osteoarthritis
A Phase 2/3 study testing Wobenzym® N in people with Knee Osteoarthritis, run by Atrium Innovations at 4 sites in Canada.
Trial summary
The objective of this study is to determine the most effective dose of Wobenzym® N versus placebo at reducing pain severity as measured by the WOMAC pain score in subjects with symptomatic knee osteoarthritis (OA) at 6 weeks of treatment. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Wobenzym® N
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 4 sitesCanada
- Study dates
- Oct 2009to Mar 2010
- Phase
- Phase 2/3
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory outpatients of either sex, between 45 and 80 years of age, inclusively, with primary OA of the knee meeting the classification criteria set by the American College of Rheumatology (ACR; Appendix C.1), and who are not expected to require surgical treatment for at least three (3) months after inclusion (Visit 1).
- Women of childbearing potential must agree to use an adequate contraception (abstinence; device mechanical barrier contraception; male partner sterilized) beginning at least seven days prior to treatment (oral birth control pill should begin at least 4 weeks prior to treatment) and continuing at least 14 days after Visit 4 or the discontinuation visit. A serum or urine pregnancy test will be performed at Visit 1.
- Functional Capacity Classification (Appendix C.2) of I-III at Visit 1.
- Except for OA, the subject is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests (Appendix B).
- Subjects with a WOMAC pain subscale index of at least 40 mm and less than or equal to 90 mm (VAS) at the Baseline Visit after a 24-hour washout of any analgesics and a minimum of 7 days washout of any NSAIDs (Appendix C.3 \& 4).
- Subjects with OA of the contra-lateral knee will be included provided contra-lateral knee OA pain intensity is inferior to the index knee.
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- Able to understand and complete study questionnaires including questions requiring a visual analog scale (VAS) response (Appendix C.4).
- Willing to participate in this study for approximately ten weeks.
- Written informed consent obtained.
- Subject agreed to follow the protocol.
Who cannot join
- Any contraindication to the use of Wobenzym® N (including allergy).
- Concurrent medical/arthritic disease that could confound or interfere with the monitoring of efficacy including, but no limited to: Inflammatory arthritis (e.g., rheumatoid arthritis), systemic lupus, spondyloarthropathy, psoriatic arthropathy, Reiter's syndrome, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, polymyalgia rheumatica and gout or pseudogout of the index knee, Paget's disease affecting the study joint, a history of septic arthritis or intra-articular fracture of the study joint, osteochondritis, dessicans or osteonecrosis of the study joint, Wilson's disease, haemochromatosis, ochronosis, chondrocalcinosis or primary osteochondromatosis.
- Significant injury of the study joint within three months of the Baseline visit as per investigator judgment.
- Subjects with Class IV functional capacity using the ACR criteria.
- Subjects who had meniscal surgery on the study knee.
- Subjects who have undergone total joint replacement of the contra-lateral knee within six months prior to the Screening Visit (Visit 1).
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- Any clinical signs or laboratory evidence for severe renal/liver/pulmonary, neurological, cardiovascular, metabolic, haematological, or psychiatric condition which in the Investigator's opinion contraindicates a 6 week course of therapy with Wobenzym® N.
- Subject is, in the opinion of the investigator, mentally or legally incapacitated preventing informed consent from being obtained, or cannot read or comprehend written material.
- Active malignancy of any type or history of a malignancy within the last five years other than basal cell carcinoma.
- Any active gastrointestinal disease.
- Use of NSAID within seven days of entering the study (Visit 2).
- Use of glucosamine sulphate, chondroitin sulphate or any other natural health product and/or OTC product that claim to be effective for pain and/or OA within 30 days of entering the study (Visit 2).
- History of drug abuse or active alcoholism.
- Any investigational drug within 30 days prior to screening.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Institut de Rhumatologie de Montréal
Montreal, Quebec, H2L 1S6
Groupe de Recherche en Rhumatologie et maladies osseuses
Québec, Quebec, G1V 3M7
Centre de Rhumatologie St-Louis
Sainte-Foy, Quebec, G1W 4R4
Centre de Recherche Musculo-Squelettique
Trois-Rivières, Quebec, G8Z 1Y2
About this study
Official title: A 6 Week, Double Blind, Placebo-controlled, Multi-center Pilot Study Evaluating the Efficacy of Wobenzym(R)N at Reducing Pain Severity as Measured by the WOMAC Pain Score in Subjects With Knee Osteoarthritis
The objective of this study is to determine the most effective dose of Wobenzym® N versus placebo at reducing pain severity as measured by the WOMAC pain score in subjects with symptomatic knee osteoarthritis (OA) at 6 weeks of treatment.
Read the detailed description
Osteoarthritis (OA) is the most common disease of the joints. The main symptom of OA is pain and later followed by stiffness and decreased function of the joints. It is estimated to affect more than 100 million people worldwide, substantially decreasing their quality of their life. Treatment that can relieve the disease symptoms and more particularly the pain level can greatly improve the quality of life and function of patients suffering from OA of weight-bearing joints such as the knee. Wobenzym® N is a fixed compound made of plant and animal enzyme products with the non-enzymatic component rutin recommended for the treatment of musculoskeletal disorders. The Wobenzym® N formulation contains, per tablet: pancreatin 100 mg, trypsin 24 mg and chymotrypsin 1 mg (from pancreas); bromelain 45 mg; papain 60 mg; and rutin 50 mg.
Over 50 clinical studies have been conducted using similar oral proteolytic enzyme preparations-- Wobenzym® and Phlogenzym®-- with consistently positive findings related to rheumatoid arthritis, sprains and strains, reduction of C-reactive protein, sports injuries and joint and muscular pain, as well as OA of the knee. Several comparative studies conducted with Phlogenzym®, an oral enzyme-rutin combination containing bromelain 90 mg, trypsin 48 mg and rutin 100 mg, have proved the product to be effective and safe in the treatment of OA as compared to NSAIDs. [For review, see Leipner, et al. Biodrugs 2001;15(12):779-89.]
- Conditions
- Knee Osteoarthritis
- Being tested
- Wobenzym® N, Placebo
- Keywords
- Osteoarthritis, Disease of joints, Wobenzym® N, WOMAC pain score, Subject reported pain (VAS)
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wobenzym® NDietary supplement
Also called None known.
4 tablets TID, 6 weeks
PlaceboDietary supplement
Also called None known.
4 tablets TID
| Study group | Role | What they receive |
|---|---|---|
| Wobenzym® N and placebo | Active comparator | Wobenzym® N 2 tablets of the treatment and 2 placebo tablets three times per day Receives: Dietary Supplement: Wobenzym® N; Dietary Supplement: Placebo |
| Wobenzym® N | Active comparator | Wobenzym® N 4 tablets three times per day Receives: Dietary Supplement: Wobenzym® N |
| Placebo | Placebo comparator | Placebo 4 tablets three times per day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the most effective dose of Wobenzym® N on the reduction of pain severity, measured by the WOMAC Osteoarthritis Index.
Measured: Baseline (day 0), Week 3 (day 21) and Week 6 (day 42)
Secondary outcomes (3)
Subject Global assessment
Measured: Week 3 (day 21) and Week 6 (day 42)
Subject assessment of pain (VAS)
Measured: Baseline (day 0), Week 3 (day 21) and Week 6 (day 42)
Inflammatory profile (serum biomarkers) in serum samples
Measured: Screening visit (-30 days prior day 0) and Week 6 (day 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atrium Innovations
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- André Beaulieu, Dr, Principal investigator, Centre de Rhymatologie St-LouisLouis Bessette, Dr, Principal investigator, Groupe de recherche en rhumatologie et maladies osseusesMorin Frédéric, Dr., Principal investigator, Centre de Recherche Musculo-SquelettiqueJean-Pierre Raynauld, Dr, Principal investigator, Institut de rhumatologie de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974428
- Sponsor's protocol ID
- A077-ATR08H
- Status last verified
- Jul 2016
- First submitted
- 9 Sep 2009
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6 Week, Double Blind, Placebo-controlled, Multi-center Pilot Study Evaluating the Efficacy of Wobenzym(R)N at Reducing Pain Severity as Measured by the WOMAC Pain Score in Subjects With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00974428
- Acronym / sponsor ID
- A077-ATR08H
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Disease of joints, Wobenzym® N, WOMAC pain score, Subject reported pain (VAS)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Atrium InnovationsIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (estimated)
- First posted
- 10 Sep 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 objective of this study is to determine the most effective dose of Wobenzym® N versus placebo at reducing pain severity as measured by the WOMAC pain score in subjects with symptomatic knee osteoarthritis (OA) at 6 weeks of treatment.
Detailed description
Osteoarthritis (OA) is the most common disease of the joints. The main symptom of OA is pain and later followed by stiffness and decreased function of the joints. It is estimated to affect more than 100 million people worldwide, substantially decreasing their quality of their life. Treatment that can relieve the disease symptoms and more particularly the pain level can greatly improve the quality of life and function of patients suffering from OA of weight-bearing joints such as the knee. Wobenzym® N is a fixed compound made of plant and animal enzyme products with the non-enzymatic component rutin recommended for the treatment of musculoskeletal disorders. The Wobenzym® N formulation contains, per tablet: pancreatin 100 mg, trypsin 24 mg and chymotrypsin 1 mg (from pancreas); bromelain 45 mg; papain 60 mg; and rutin 50 mg.
Over 50 clinical studies have been conducted using similar oral proteolytic enzyme preparations-- Wobenzym® and Phlogenzym®-- with consistently positive findings related to rheumatoid arthritis, sprains and strains, reduction of C-reactive protein, sports injuries and joint and muscular pain, as well as OA of the knee. Several comparative studies conducted with Phlogenzym®, an oral enzyme-rutin combination containing bromelain 90 mg, trypsin 48 mg and rutin 100 mg, have proved the product to be effective and safe in the treatment of OA as compared to NSAIDs. [For review, see Leipner, et al. Biodrugs 2001;15(12):779-89.]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wobenzym® N and placebo | Active comparator | Dietary Supplement: Wobenzym® N, Dietary Supplement: PlaceboWobenzym® N 2 tablets of the treatment and 2 placebo tablets three times per day |
| Wobenzym® N | Active comparator | Dietary Supplement: Wobenzym® NWobenzym® N 4 tablets three times per day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo 4 tablets three times per day |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ambulatory outpatients of either sex, between 45 and 80 years of age, inclusively, with primary OA of the knee meeting the classification criteria set by the American College of Rheumatology (ACR; Appendix C.1), and who are not expected to require surgical treatment for at least three (3) months after inclusion (Visit 1).
- Women of childbearing potential must agree to use an adequate contraception (abstinence; device mechanical barrier contraception; male partner sterilized) beginning at least seven days prior to treatment (oral birth control pill should begin at least 4 weeks prior to treatment) and continuing at least 14 days after Visit 4 or the discontinuation visit. A serum or urine pregnancy test will be performed at Visit 1.
- Functional Capacity Classification (Appendix C.2) of I-III at Visit 1.
- Except for OA, the subject is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests (Appendix B).
- Subjects with a WOMAC pain subscale index of at least 40 mm and less than or equal to 90 mm (VAS) at the Baseline Visit after a 24-hour washout of any analgesics and a minimum of 7 days washout of any NSAIDs (Appendix C.3 \& 4).
Key exclusion criteria (14 listed)
- Any contraindication to the use of Wobenzym® N (including allergy).
- Concurrent medical/arthritic disease that could confound or interfere with the monitoring of efficacy including, but no limited to: Inflammatory arthritis (e.g., rheumatoid arthritis), systemic lupus, spondyloarthropathy, psoriatic arthropathy, Reiter's syndrome, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, polymyalgia rheumatica and gout or pseudogout of the index knee, Paget's disease affecting the study joint, a history of septic arthritis or intra-articular fracture of the study joint, osteochondritis, dessicans or osteonecrosis of the study joint, Wilson's disease, haemochromatosis, ochronosis, chondrocalcinosis or primary osteochondromatosis.
- Significant injury of the study joint within three months of the Baseline visit as per investigator judgment.
- Subjects with Class IV functional capacity using the ACR criteria.
- Subjects who had meniscal surgery on the study knee.
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® NAlso: None known.4 tablets TID, 6 weeks | Dietary supplement | Wobenzym® N, Wobenzym® N and placebo |
| PlaceboAlso: None known.4 tablets TID | Dietary supplement | Placebo, Wobenzym® N and placebo |
Primary outcome
Determination of the most effective dose of Wobenzym® N on the reduction of pain severity, measured by the WOMAC Osteoarthritis Index.
Time frame: Baseline (day 0), Week 3 (day 21) and Week 6 (day 42)
3 secondary outcomes
Subject Global assessment
Time frame: Week 3 (day 21) and Week 6 (day 42)
Subject assessment of pain (VAS)
Time frame: Baseline (day 0), Week 3 (day 21) and Week 6 (day 42)
Inflammatory profile (serum biomarkers) in serum samples
Time frame: Screening visit (-30 days prior day 0) and Week 6 (day 42)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
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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.
André Beaulieu, Dr principal investigator
Centre de Rhymatologie St-Louis
Louis Bessette, Dr principal investigator
Groupe de recherche en rhumatologie et maladies osseuses
Morin Frédéric, Dr. principal investigator
Centre de Recherche Musculo-Squelettique
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Wobenzym® N in people with Knee Osteoarthritis, run by Atrium Innovations at 4 sites in Canada.
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 10 inclusion and 14 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: withdrawn, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Determination of the most effective dose of Wobenzym® N on the reduction of pain severity, measured by the WOMAC Osteoarthritis Index. (time frame: Baseline (day 0), Week 3 (day 21) and Week 6 (day 42)). 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 12 Jul 2016.