Phase 3
N=163
Efficacy Study of Condrosulf in the Treatment of Symptomatic OA of the Hand
Osteoarthrosis
Bottom Line
View on ClinicalTrials.gov: NCT00291499 ↗Enrolled (actual)
163
Serious AEs
2.5%
Results posted
Mar 2021
Primary outcome: Primary: Change in Global Spontaneous Pain Intensity of Target Hand — -20; -11.3 mm — p=0.016
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Chondroitin 4&6 sulfate (Condrosulf) (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- IBSA Institut Biochimique SA
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Global Spontaneous Pain Intensity of Target Hand |
-20; -11.3 | 0.016 sig |
| PRIMARY Change in Functional Index for Hand Osteoarthritis Dreiser's Score (FIHOA) in the Target Hand |
-2.9; -0.7 | 0.008 sig |
| SECONDARY Investigator Global Evaluation on Efficacy |
15; 9; 20; 16; 16; 10 | 0.043 sig |
| SECONDARY Change in Grip Strength |
2.5; 0.6 | 0.132 |
| SECONDARY Change in Morning Stiffness Duration |
-4.8; 0.3 | 0.031 sig |
| SECONDARY Consumption of Paracetamol |
1.9; 2.0 | <0.05 sig |
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 (Huskisson's Visual Analogue Scale: VAS) and the score of Dreiser's algo-functional index (FIHOA) during the treatment with the tested product, Condrosulf®, versus placebo.
Eligibility Criteria
Inclusion Criteria
- Patients of either sex
- Aged 40 and over
- Outpatients
- Patients fulfilling the American Congress of Rheumatology (ACR) criteria for the reporting of hand OA
- Patients showing X-ray features of hand OA on at least two joints (2 IP and/or 1 IP and 1 TMC) of the dominant hand on standard plain radiographs ( or = 40 mm at inclusion time).
- Showing a FIHOA score > or = 6.
- Having had at least two painful flares in a finger joint during the previous 12 month.
- Patients who have signed the written informed consent for their participation in the study
- Patients able to understand and follow the protocol.
- Patients with a satisfying health and nutritional status.
- Female subjects of childbearing potential using, within three months prior to the inclusion in the study, a reliable form of contraception during the course of the study (oral contraceptive pill, intrauterine device or condoms) or female of non childbearing potential (hysterectomy, bilateral ovariectomy or tubal section/ligation).
- Female subjects of childbearing potential with a negative urinary pregnancy test before the inclusion in the study.
Exclusion Criteria
- Inflammatory joint disease of other origin
- Septic arthritis
- Chronic inflammatory joint disease
- Previous articular fracture of the concerned articulations
- Use of analgesic therapy for other indications
- Receiving oral corticosteroids
- Mono-articular posttraumatic OA of the finger
- Planning surgery of the hands in the following 6 months
- Patients suffering or having suffered from secondary osteoarthritis after one of the following diseases:
- Infectious arthritis - Acromegaly
- Ochronosis - Hemachromatosis
- Gout - Wilson's disease
- Chondrocalcinosis - Paget's disease
- Osteochondrosis - Mutation of collagen
- Genetic problems (for ex. hypermobility) - Previous joint fracture
- Arthropathies of different aetiologies - Algodystrophy (M. Sudeck)
- Congenital abnormalities
- Recurrent pseudogout
- Major dysplasias
- Intra-articular injection in a hand joint from less than 3 months
- Basic treatment of arthritis with symptom-modifying agents (chondroitin sulfate, glucosamine sulfate, diacerhein, hyaluronic acid) in the last 3 months
- Articular lavage in the last 3 months
- Treatment with corticoids, by any administration route during the last month
- Patient suffering from frequent asthma crises
- Physiotherapy, re-education, alternative medicine (mesotherapy, acupuncture) on the hands foreseeable in the next year
- Serious organic diseases: heart failure, renal or hepatic insufficiency, blood dyscrasia, serious infection
- Participation in other clinical trials in the two months preceding the study
- Known or ascertained hypersensitivity to the active ingredient of the tested drug.
- Patients refusing to sign the written informed consent form
- Patients who do not co-operate, not respecting the protocol requirements
- Pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT00291499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.