Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291499
Status:
COMPLETED
Last Update Posted:
2021-03-04
First Post:
2006-02-13
Brief Title:
Efficacy Study of Condrosulf in the Treatment of Symptomatic OA of the Hand
Sponsor:
IBSA Institut Biochimique SA
Organization:
IBSA Institut Biochimique SA
Study Overview
Official Title:
Clinical Evaluation of Condrosulf 800 mg in the Treatment of Symptomatic OA of the Hand a 6-month Double-blind Placebo Controlled Study
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of the present study is to investigate the effectiveness of Condrosulf 800 mg tablets vs placebo once a day for 6 months in the symptomatic treatment of finger joint osteoarthritis
Primary endpoints of the study are the evaluation of global spontaneous pain Huskissons Visual Analogue Scale VAS and the score of Dreisers algo-functional index FIHOA during the treatment with the tested product Condrosulf versus placebo
Primary endpoints of the study are the evaluation of global spontaneous pain Huskissons Visual Analogue Scale VAS and the score of Dreisers algo-functional index FIHOA during the treatment with the tested product Condrosulf versus placebo
Detailed Description:
The goal of the present study is to investigate the effectiveness of Condrosulf 800 mg tablets vs placebo once a day for 6 months in the symptomatic treatment of finger joint osteoarthritis in 160 randomised patients
Primary endpoints
Primary endpoints of the study are the evaluation of global spontaneous pain Huskissons Visual Analogue Scale VAS and the score of Dreisers algo-functional index FIHOA during the treatment with the tested product Condrosulf versus placebo
Secondary endpoints are
Efficacy evaluation Global impression of efficacy expressed by the patient and the physician VAS Grip strength measured manometrically Morning stiffness duration Consumption of Paracetamol Tolerability 4-point verbal scale Adverse Events occurring during the treatment period Other parametersTreatment compliance Biological markers of arthritis
Primary endpoints
Primary endpoints of the study are the evaluation of global spontaneous pain Huskissons Visual Analogue Scale VAS and the score of Dreisers algo-functional index FIHOA during the treatment with the tested product Condrosulf versus placebo
Secondary endpoints are
Efficacy evaluation Global impression of efficacy expressed by the patient and the physician VAS Grip strength measured manometrically Morning stiffness duration Consumption of Paracetamol Tolerability 4-point verbal scale Adverse Events occurring during the treatment period Other parametersTreatment compliance Biological markers of arthritis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None