Multi-Center Study Evaluating the Efficacy of Wobenzym(R)N in Treating Knee Osteoarthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Atrium Innovations.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Atrium Innovations
ClinicalTrials.gov Identifier:
NCT00974428
First received: September 9, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Dietary Supplement: Wobenzym® N
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Atrium Innovations:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Subject Global assessment [ Time Frame: Week 3 (day 21) and Week 6 (day 42) ] [ Designated as safety issue: Yes ]
  • Subject assessment of pain (VAS) [ Time Frame: Baseline (day 0), Week 3 (day 21) and Week 6 (day 42) ] [ Designated as safety issue: Yes ]
  • Inflammatory profile (serum biomarkers) in serum samples [ Time Frame: Screening visit (-30 days prior day 0) and Week 6 (day 42) ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2009
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Wobenzym® N and placebo
Wobenzym® N 2 tablets of the treatment and 2 placebo tablets three times per day
Dietary Supplement: Wobenzym® N
4 tablets TID, 6 weeks
Other Name: None known.
Dietary Supplement: Placebo
4 tablets TID
Other Name: None known.
Active Comparator: Wobenzym® N
Wobenzym® N 4 tablets three times per day
Dietary Supplement: Wobenzym® N
4 tablets TID, 6 weeks
Other Name: None known.
Placebo Comparator: Placebo
Placebo 4 tablets three times per day
Dietary Supplement: Placebo
4 tablets TID
Other Name: None known.

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.]

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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).
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974428

Locations
Canada, Quebec
Institut de Rhumatologie de Montréal Not yet recruiting
Montreal, Quebec, Canada, H2L 1S6
Contact: Jean-Pierre Raynauld, Dr    514-523-8603    jp.raynauld@videotron.ca   
Principal Investigator: Jean-Pierre Raynauld, Dr         
Sub-Investigator: Denis Choquette, Dr         
Sub-Investigator: Boulos Haraoui, Dr         
Centre de Rhumatologie St-Louis Not yet recruiting
Sainte-foy, Quebec, Canada, G1W 4R4
Contact: André Beaulieu, Dr    418-659-5757    ab5@videotron.ca   
Principal Investigator: André Beaulieu, Dr         
Sub-Investigator: René Therrien, Dr         
Sub-Investigator: Pierre Lachance, Dr         
Centre de Recherche Musculo-Squelettique Not yet recruiting
Trois-Rivieres, Quebec, Canada, G8Z 1Y2
Contact: Frédéric Morin, Dr    819-370-1301    crms@cgocable.ca   
Principal Investigator: Frédéric Morin, Dr         
Sub-Investigator: Jean-Luc Tremblay, Dr         
Sub-Investigator: Clode Lessard, Dr         
Sub-Investigator: Michele Dessureault, Dr         
Canada
Groupe de Recherche en Rhumatologie et maladies osseuses Not yet recruiting
Quebec, Canada, G1V 3M7
Contact: Louis Bessette, Dr    418-650-2661    groupederecherche@grmo.net   
Principal Investigator: Louis Bessette, Dr         
Sub-Investigator: Jacques Brown, Dr         
Sub-Investigator: Louise Morin, Dr.         
Sub-Investigator: Marie-Claire Banville, Dr         
Sponsors and Collaborators
Atrium Innovations
Investigators
Principal Investigator: André Beaulieu, Dr Centre de Rhymatologie St-Louis
Principal Investigator: Louis Bessette, Dr Groupe de recherche en rhumatologie et maladies osseuses
Principal Investigator: Morin Frédéric, Dr. Centre de Recherche Musculo-Squelettique
Principal Investigator: Jean-Pierre Raynauld, Dr Institut de Rhumatologie de Montréal
  More Information

No publications provided

Responsible Party: Barry W. Ritz/Vice President for Scientific Affairs, Atrium Innovations
ClinicalTrials.gov Identifier: NCT00974428     History of Changes
Other Study ID Numbers: A077-ATR08H
Study First Received: September 9, 2009
Last Updated: September 9, 2009
Health Authority: Canada: Health Canada

Keywords provided by Atrium Innovations:
Osteoarthritis
Disease of joints
Wobenzym® N
WOMAC pain score
Subject reported pain (VAS)

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Wobenzym
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014