NCT00974428

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

4 active sites

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

5 months

First QC Date

September 9, 2009

Last Update Submit

July 11, 2016

Conditions

Knee Osteoarthritis

Keywords

OsteoarthritisDisease of jointsWobenzym® NWOMAC pain scoreSubject reported pain (VAS)

Outcome Measures

Primary Outcomes (1)

  • Determination of the most effective dose of Wobenzym® N on the reduction of pain severity, measured by the WOMAC Osteoarthritis Index.

    Baseline (day 0), Week 3 (day 21) and Week 6 (day 42)

Secondary Outcomes (3)

  • Subject Global assessment

    Week 3 (day 21) and Week 6 (day 42)

  • Subject assessment of pain (VAS)

    Baseline (day 0), Week 3 (day 21) and Week 6 (day 42)

  • Inflammatory profile (serum biomarkers) in serum samples

    Screening visit (-30 days prior day 0) and Week 6 (day 42)

Study Arms (3)

Wobenzym® N and placebo

ACTIVE COMPARATOR

Wobenzym® N 2 tablets of the treatment and 2 placebo tablets three times per day

Dietary Supplement: Wobenzym® NDietary Supplement: Placebo

Wobenzym® N

ACTIVE COMPARATOR

Wobenzym® N 4 tablets three times per day

Dietary Supplement: Wobenzym® N

Placebo

PLACEBO COMPARATOR

Placebo 4 tablets three times per day

Dietary Supplement: Placebo

Interventions

Wobenzym® NDIETARY_SUPPLEMENT

4 tablets TID, 6 weeks

Also known as: None known.
Wobenzym® NWobenzym® N and placebo
PlaceboDIETARY_SUPPLEMENT

4 tablets TID

Also known as: None known.
PlaceboWobenzym® N and placebo

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Institut de Rhumatologie de Montréal

Montreal, Quebec, H2L 1S6, Canada

Location

Groupe de Recherche en Rhumatologie et maladies osseuses

Québec, Quebec, G1V 3M7, Canada

Location

Centre de Rhumatologie St-Louis

Sainte-Foy, Quebec, G1W 4R4, Canada

Location

Centre de Recherche Musculo-Squelettique

Trois-Rivières, Quebec, G8Z 1Y2, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2009

First Posted

September 10, 2009

Study Start

October 1, 2009

Primary Completion

March 1, 2010

Last Updated

July 12, 2016

Record last verified: 2016-07

Locations

CA(4)