Study of Association of Anti-inflammatory and Anti-rheumatic
ZDPC00213
Phase III Study Comparing Association of Anti-inflammatory and Anti-rheumatic
1 other identifier
interventional
375
0 countries
N/A
Brief Summary
Phase III Study, double-blind, comparing association of anti-inflammatory and anti-rheumatic in 375 subjects with knee osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2015
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2015
CompletedFirst Posted
Study publicly available on registry
May 19, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedMay 19, 2015
May 1, 2015
11 months
May 11, 2015
May 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
12 weeks
Secondary Outcomes (1)
Safety measured by frequency of adverse event
12 weeks
Study Arms (3)
Kit 1 ( ML + CG ) + P
EXPERIMENTALOne sachet meloxicam and glucosamine and 1 placebo tablet once a day for 12 weeks One sachet
Kit 2 ( ML + P)
ACTIVE COMPARATOROne tablet of meloxicam and one sachet of placebo once per day for 12 weeks
Kit 3 ( P+ GC)
ACTIVE COMPARATOROne sachet of glucosamine and one tablet placebo once a day for 12 weeks
Interventions
Experimental
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Cardiovascular disease
- Serious chronic comorbidity
- Hypersensitivity to any component of the study drugs
- body mass index\> 30 kg / m²
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Edio Costa, Doctor
CRM
Central Study Contacts
Valery F Carvalho, Biologist
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2015
First Posted
May 19, 2015
Study Start
July 1, 2015
Primary Completion
June 1, 2016
Study Completion
July 1, 2016
Last Updated
May 19, 2015
Record last verified: 2015-05