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

• ClinicalTrials.gov Identifier: NCT03936192
• Recruitment Status: Unknown
• First Posted: May 3, 2019
• Last Update Posted: May 6, 2019
• Sponsor: Eurofarma Laboratorios S.A.
• Information provided by (Responsible Party): Eurofarma Laboratorios S.A.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Knee Osteoarthritis	Drug: glucosamine sulphate 1500mg and meloxicam 15mg; Drug: Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg; Drug: Placebos	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 645 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

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

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

Placebo administered once daily for 12 weeks.

• Masking: Double (Participant, Investigator)
• Masking Description: Participant and Investigator
• Primary Purpose: Treatment
• Official Title: A Parallel-group Active Comparator, Double-blind, Multicenter, Randomized, Double-blind, Phase III Clinical Study to Assess the Safety and Efficacy of Glucosamine Sulfate Plus Meloxicam Versus Glucosamine Sulfate Plus Chondroitin Sulfate in Treatment of Primary Symptomatic Knee Osteoarthritis.
• Estimated Study Start Date: October 1, 2019
• Estimated Primary Completion Date: January 1, 2020
• Estimated Study Completion Date: October 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.
Active Comparator: 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.	Drug: Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg; Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg, manufactured by Zodiac Pharmaceutical Products S.A. (Condroflex®)
Placebo Comparator: Placebo; Placebo administered once daily for 12 weeks	Drug: Placebos; Placebo administered once daily for 12 weeks.

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: 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);

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Cassiano Berto; +551150908600 ext 8412; cassiano.berto@eurofarma.com.br

Contact: Sandra Rodrigues; +551150908600 ext 8417; sandra.rodrigues@eurofarma.com.br

Sponsors and Collaborators

Eurofarma Laboratorios S.A.

More Information

• Responsible Party: Eurofarma Laboratorios S.A.
• ClinicalTrials.gov Identifier: NCT03936192
• Other Study ID Numbers: EF 156
• First Posted: May 3, 2019
• Last Update Posted: May 6, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: It is not yet known if there will be a plan to make IPD available.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Meloxicam; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action