A Parallel-group Active Comparator, Double-blind, Multicenter, Randomized, Double-blind, Phase III Clinical Study

NCT ID: NCT03936192

Last Updated: 2022-04-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2021-02-28

Brief Summary

A multicenter, randomized, double-blind, parallel-group, placebo-controlled, and active-drug, 12-week, multicenter clinical study. Participants will be randomized 2: 2: 1 to receive the combination of glucosamine sulfate + meloxicam (experimental group), combination of glucosamine sulfate + chondroitin sulfate (active control group) or placebo.

Detailed Description

A multicenter, randomized, double-blind, parallel-group, placebo-controlled, and active-drug, 12-week treatment period, phase 3 comparative clinical study. Participants will be randomized 2:2:1 to receive the combination of glucosamine sulfate + meloxicam (experimental group), combination of glucosamine sulfate + chondroitin sulfate (active control group) or placebo.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

glucosamine sulfate 1500mg and meloxicam 15mg (Eurofarma)

glucosamine sulfate 1500mg plus meloxicam 15mg combination, manufactured by Eurofarma Laboratories S.A., administered once a day for 12 weeks.

Group Type: EXPERIMENTAL

glucosamine sulphate 1500mg and meloxicam 15mg

Intervention Type: DRUG

glucosamine sulphate 1500mg plus meloxicam 15mg, manufactured by Eurofarma Laboratories S.A., administered once a day for 12 weeks.

Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg

Glucosamine sulfate 1500mg plus Chondroitin Sulfate 1200mg, manufactured by Zodiac Pharmaceutical Products S.A. (Condroflex®), given once daily for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg

Intervention Type: DRUG

Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg, manufactured by Zodiac Pharmaceutical Products S.A. (Condroflex®)

Placebo

Placebo administered once daily for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Placebo administered once daily for 12 weeks.

Interventions

glucosamine sulphate 1500mg and meloxicam 15mg

glucosamine sulphate 1500mg plus meloxicam 15mg, manufactured by Eurofarma Laboratories S.A., administered once a day for 12 weeks.

Intervention Type: DRUG

Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg

Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg, manufactured by Zodiac Pharmaceutical Products S.A. (Condroflex®)

Intervention Type: DRUG

Placebos

Placebo administered once daily for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

glucosamine sulfate 1500mg and meloxicam 15mg (Eurofarma); glucosamine sulfate 1500mg and chondroitin sulfate 1200mg (Eurofarma)

Eligibility Criteria

Inclusion Criteria

1. Age of 40 to 75 years (both inclusive).

2. Clinical and radiological diagnosis of primary (idiopathic) knee osteoarthritis according to the American College of Rheumatology (ACR) criteria.

3. Radiological classification of Kellgren and Lawrence of grades 2 or 3 on X-ray of the target knee.

4. Presence of painful symptoms in the target knee in the last 3 months due to osteoarthritis.

5. Visual analogue scale for evaluation of knee osteoarthritis pain by the research participant ≥ 40 mm at the screening visit.

6. Mean score ≥ 40mm on the "pain" subscale (0 to 100mm) on the target knee of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire at the randomization visit.

7. ACR functional class from I to III.

8. Signature of the Informed Consent Form before performing any study procedure.

Exclusion Criteria

1. Diagnosis of septic arthritis, inflammatory arthritis (such as rheumatoid arthritis), gout, pseudogout, Paget's disease, dysplasias or congenital articular anomalies.

2. Severe joint misalignment in the target knee, defined by the researcher.

3. History of severe trauma or surgery (including arthroscopy) in the target knee within 6 months prior to the study selection visit.

4. Symptomatic osteoarthritis of the ipsilateral hip.

5. Use of non-steroidal anti-inflammatory, dipyrone, opioid or narcotic analgesics, collagen and herbal remedies for osteoarthritis from the screening visit, or a washout period for such drugs less than those defined by the protocol, prior to the visit randomization. The use of antidepressants and pain modulating medicinal products should not be started from the screening visit, but they should be kept stable during the study if they are already being used prior to the screening visit.

6. Oral, intravenous or intramuscular corticosteroid therapy within 30 days prior to study visit visit.

7. Intra-articular injection of corticosteroids, hyaluronic acid and / or platelet-rich plasma at the target knee within 6 months prior to the study selection visit.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

EF 156

Identifier Type: -

Identifier Source: org_study_id