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

Eurofarma

Status and phase: Withdrawn; Phase 3

Conditions: Knee Osteoarthritis

Treatments: Drug: Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg; Drug: glucosamine sulphate 1500mg and meloxicam 15mg; Drug: Placebos

Study type: Interventional

Funder types: Industry

Identifiers

NCT03936192

EF 156

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups, including a placebo group

glucosamine sulfate 1500mg and meloxicam 15mg (Eurofarma)

Experimental group

Description:

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

Treatment:

Drug: glucosamine sulphate 1500mg and meloxicam 15mg

Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg

Active Comparator group

Description:

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

Treatment:

Drug: Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg

Placebo

Placebo Comparator group

Description:

Placebo administered once daily for 12 weeks

Treatment:

Drug: Placebos