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

Knee Osteoarthritis Clinical Trial

— SAVE  

Official title:

Parallel-group Active Comparator, Double-blind, Randomized, Phase III Study to Assess Safety, Efficacy of Glucosamine Sulfate Plus Meloxicam vs Glucosamine Sulfate Plus Chondroitin Sulfate Primary Symptomatic Knee Osteoarthritis Treatment

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03936192
• Other study ID #: EF 156
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 2019
• Est. completion date: February 2021

Study information

• Verified date: April 2022
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• 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.
• Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg
Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg, manufactured by Zodiac Pharmaceutical Products S.A. (Condroflex®)
• Placebos
Placebo administered once daily for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess whether the efficacy of glucosamine + meloxicam sulfate treatment is superior to the efficacy of treatment with glucosamine sulfate + chondroitin sulfate in improving pain in subjects with symptomatic primary knee OA treated for 4 weeks.	Absolute variation of the "pain" subscale score of the WOMAC questionnaire (0 to 100mm) 4 weeks (V2) after starting treatment in relation to the basal score (VR);	4 weeks