Back to resultsStudy of Association of Anti-inflammatory and Anti-rheumatic (ZDPC00213)
Primary Purpose
Osteoarthritis
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Meloxicam and Glucosamine
Meloxicam
Glucosamine
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring pain, Knee
Eligibility Criteria
Inclusion Criteria:
- Signs the Informed Consent Form
- Age between 40 and 85 years
- osteoarthritis of the knee according to clinical and radiological criteria of the American College of Rheumatology
Exclusion Criteria:
- Cardiovascular disease
- Serious chronic comorbidity
- Hypersensitivity to any component of the study drugs
- body mass index> 30 kg / m²
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Kit 1 ( ML + CG ) + P
Kit 2 ( ML + P)
Kit 3 ( P+ GC)
Arm Description
One sachet meloxicam and glucosamine and 1 placebo tablet once a day for 12 weeks One sachet
One tablet of meloxicam and one sachet of placebo once per day for 12 weeks
One sachet of glucosamine and one tablet placebo once a day for 12 weeks
Outcomes
Primary Outcome Measures
Efficacy measured by decrease in score algofunctional Lequesne index after 12 weeks from the start of treatment
Decrease in score of algofunctional Lequesne index after 12 weeks from the start of treatment
Secondary Outcome Measures
Safety measured by frequency of adverse event
Safety as measured by total frequency of adverse event during the 12 weeks of treatment
Full Information
NCT ID
NCT02448199
First Posted
May 11, 2015
Last Updated
May 18, 2015
Sponsor
Zodiac Produtos Farmaceuticos S.A.
Collaborators
Eurotrials Brasil Consultores Cientificos Ltda
1. Study Identification
Unique Protocol Identification Number
NCT02448199
Brief Title
Study of Association of Anti-inflammatory and Anti-rheumatic
Acronym
ZDPC00213
Official Title
Phase III Study Comparing Association of Anti-inflammatory and Anti-rheumatic
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zodiac Produtos Farmaceuticos S.A.
Collaborators
Eurotrials Brasil Consultores Cientificos Ltda
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phase III Study, double-blind, comparing association of anti-inflammatory and anti-rheumatic in 375 subjects with knee osteoarthritis.
Detailed Description
Evaluation after 12 weeks of treatment, in 3 arms, the efficacy and safety of the association.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
pain, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
375 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Kit 1 ( ML + CG ) + P
Arm Type
Experimental
Arm Description
One sachet meloxicam and glucosamine and 1 placebo tablet once a day for 12 weeks One sachet
Arm Title
Kit 2 ( ML + P)
Arm Type
Active Comparator
Arm Description
One tablet of meloxicam and one sachet of placebo once per day for 12 weeks
Arm Title
Kit 3 ( P+ GC)
Arm Type
Active Comparator
Arm Description
One sachet of glucosamine and one tablet placebo once a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Meloxicam and Glucosamine
Other Intervention Name(s)
Association Anti-inflamatory/Anti-rheumatic
Intervention Description
Experimental
Intervention Type
Drug
Intervention Name(s)
Meloxicam
Other Intervention Name(s)
Anti-inflamatory/Placebo
Intervention Description
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Glucosamine
Other Intervention Name(s)
Anti-rheumatic/Placebo
Intervention Description
Active Comparator
Primary Outcome Measure Information:
Title
Efficacy measured by decrease in score algofunctional Lequesne index after 12 weeks from the start of treatment
Description
Decrease in score of algofunctional Lequesne index after 12 weeks from the start of treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Safety measured by frequency of adverse event
Description
Safety as measured by total frequency of adverse event during the 12 weeks of treatment
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signs the Informed Consent Form
Age between 40 and 85 years
osteoarthritis of the knee according to clinical and radiological criteria of the American College of Rheumatology
Exclusion Criteria:
Cardiovascular disease
Serious chronic comorbidity
Hypersensitivity to any component of the study drugs
body mass index> 30 kg / m²
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carine F Sanches, Pharmacist
Phone
55 11 55015332
Email
carine.sanches@zodiac.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Valery F Carvalho, Biologist
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edio Costa, Doctor
Organizational Affiliation
CRM
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Study of Association of Anti-inflammatory and Anti-rheumatic
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