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Clinical Study of Non-inferiority With Participants Diagnosed With Primary Knee OA (GLACIAL) (GLACIAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02830919
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.

Brief Summary:
This phase III clinical study will be conducted in Brazilian research sites. It will be included in the study 314 participants diagnosed with primary knee OA according to the classification criteria of the ACR. After a washout period, the participants will be randomized to receive the combination of glucosamine sulfate + chondroitin sulfate of bovine origin of Eurofarma Laboratorios S.A. (N= 157) or the combination of glucosamine sulfate + chondroitin sulfate of Zodiac Pharmaceuticals S.A. Condroflex ® (N = 157). The treatment period of the study will be of 24 weeks. Each participant will perform seven visits to the research site. The main evaluations will be the improve of pain in the target knee by questionnaire Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and quality of life by SF-12 questionnaire.

Condition or disease Intervention/treatment Phase
Osteoarthritis of Knee Drug: Glucosamine and chondroitin sulfate combination (Eurofarma) Drug: Glucosamine and chondroitin sulfate combination (Zodic) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 627 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Phase III Clinical Study, Multicenter, Randomized, Single-blind, Parallel Groups for Safety Evaluation and Non-inferiority of Efficacy of Glucosamine Sulfate Plus Chondroitin Sulfate From Bovine Origin (Eurofarma Laboratorios S.A.) Versus Condroflex ® in the Treatment of Symptomatic Knee Primary Osteoarthritis
Actual Study Start Date : December 5, 2016
Actual Primary Completion Date : May 10, 2019
Actual Study Completion Date : May 10, 2019


Arm Intervention/treatment
Experimental: Glucosamine and chondroitin sulfate combination (Eurofarma)
Glucosamine sulfate 1500mg plus chondroitin sulfate 1200mg combination, manufactured by Eurofarma Laboratórios S.A., administered once a day for 24 weeks.
Drug: Glucosamine and chondroitin sulfate combination (Eurofarma)
Active Comparator: Glucosamine and chondroitin sulfate combination (Zodiac)
Glucosamine sulfate 1500mg plus chondroitin sulfate 1200mg combination, manufactured by Zodiac Produtos Farmacêuticos S.A. (Condroflex®), administered once a day for 24 weeks.
Drug: Glucosamine and chondroitin sulfate combination (Zodic)



Primary Outcome Measures :
  1. Absolute change of pain WOMAC subscale score 24 weeks after initiation of treatment. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Absolute change the overall assessment of the disease by the investigator along treatment as measured by Visual Analog Scale from 0 to 100mm. [ Time Frame: 24 weeks ]
  2. Absolute change score of physical and mental components of the questionnaire SF-12 24 weeks after initiation of treatment compared to baseline. [ Time Frame: 24 weeks ]
  3. Incidence and profile of adverse events coded as MedDRA by treatment group. [ Time Frame: 24 weeks ]
  4. Frequency of treatment discontinuation for adverse events and laboratory abnormalities. [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male and female patients meeting all the following criteria will be enrolled in the study:

  1. Aged ≥ 40 years.
  2. Clinical and radiological diagnosis of primary (idiopathic) arthrosis of knee according to the criteria of the American College of Rheumatology (ACR).
  3. Kellgren and Lawrence radiological classification of degree 2 or 3 in x-ray of knee-target obtained in 3 months prior to the screening visit of the study.
  4. Presence of painful symptoms in the target knee in the last 3 months due to osteoarthritis.
  5. Visual analogue scale for evaluation of the pain of osteoarthritis of knee by the research participant in the screening visit ≥ 40 mm
  6. Average score ≥ 40 mm in the subscale of "pain" (from 0 to 100 mm) in the target knee of the questionnaire Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in the randomization visit.
  7. Functional class ACR from I to III.
  8. Signing the Informed Consent Form (ICF) before the performance of any study procedure.

Exclusion Criteria:

Patients meeting at least one of the following criteria will be excluded from the study:

  1. Diagnosis of septic arthritis, inflammatory arthritis (as rheumatoid arthritis), gout, pseudogout, Paget's disease, dysplasias or congenital joint abnormalities.
  2. Presence of inflammatory signals (edema, erythema or joint effusion) in the target knee, considered to be clinically significant by investigator.
  3. Serious target knee joint misalignment, defined by investigator.
  4. Predominantly patellofemoral Osteoarthritis in the target knee.
  5. Historical of severe trauma or surgery (including arthroscopy) in the target knee in the 6 months before the screening visit.
  6. Planned Surgery to the target knee
  7. Symptomatic Osteoarthritis of the ipsilateral hip.
  8. Use of non-steroidal anti-inflammatory, dipyrone and opioid analgesics or narcotics from the screening visit, or a washout period for these medicines less than those defined by the Protocol, before the randomization visit .
  9. Oral Glucocorticoids, intravenously or intramuscularly in the 30 days prior to the screening visit.
  10. Intraarticular corticosteroid Injection and/or hyaluronic acid in the target knee in 6 months prior to the screening visit.
  11. Use of the following drugs in the periods described below, before the screening visit:

    1. Diacerein, chloroquine or soybean and avocado unsaponifiables extracts in the last 3 months.
    2. Duloxetine hydrochloride in the last 30 days.
    3. Glucosamine Sulphate and/or chondroitin sulfate in the last 6 months.
    4. Strontium ranelate for the past 6 months.
  12. Historical of allergy or intolerance to treatment of the study or to paracetamol.
  13. Physiotherapy or irregular practice of physical activity beginning in the 3 months prior to the screening visit.
  14. Diagnosis of fibromyalgia, collagenosis or significative vascular/neurologica diseases in lower limbs that may confuse the analysis of the study.
  15. Body mass index ≥ 40 kg/m2.
  16. Need to use cane, crutches or a walker.
  17. Presence of infectious hepatitis active or history of hepatitis medicinal products.
  18. Results of ALT, AST and total bilirubin and fractions above the upper limit of normal.
  19. Serum creatinine level above the upper limit of normal.
  20. Fasting blood glucose > 110 mg/dL or glycated hemoglobin > 6.5%.
  21. Use of anticoagulants.
  22. Consumption of alcohol more than one dose a day (women) or two doses a day (men).
  23. Presence of serious diseases or not controlled.
  24. Planned surgery to occur during the period of participation in the study.
  25. Presence of pregnancy or breastfeeding.
  26. Women of childbearing potential must agree to use highly effective contraception.
  27. Participation in a clinical trial protocol within the previous 12 months unless, at the investigator's discretion, his or her participation may imply a direct benefit for the participant.
  28. Presence of any condition which, at the investigator's discretion, may consider the participation of the patient inadequate for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830919


Locations
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Brazil
Goiânia, Goiás, Brazil
Maringá, Paraná, Brazil
Curitiba, PR, Brazil
São Paulo, SP, Brazil
Sponsors and Collaborators
Eurofarma Laboratorios S.A.

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Responsible Party: Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier: NCT02830919    
Other Study ID Numbers: EF140
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Keywords provided by Eurofarma Laboratorios S.A.:
Osteoarthritis of knee
Glucosamine sulfate
Chondroitin sulfate
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases