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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.
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 (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.
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 parameters:Treatment compliance; Biological markers of arthritis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chondroitin 4&6 sulfate (Condrosulf) | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chondroitin 4&6 sulfate (Condrosulf) | Drug | 800 mg/day for 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Global Spontaneous Pain Intensity of Target Hand | Intensity of global spontaneous pain is evaluated by the patient himself on a Huskisson's visual analogue scale (VAS) of 100 mm. 0=no pain 100=max pain Change calculated as difference between Month 6 value and baseline value target hand is defined as the patient's most symptomatic hand or, when both hands were equally painful, the patient's dominant hand. | 6 months |
| Change in Functional Index for Hand Osteoarthritis Dreiser's Score (FIHOA) in the Target Hand | Functional Index for Hand Osteoarthritis (Dreiser's Index). Range 0-30 Patients reported the severity of their symptoms by answering a set of 10 questions. Severity was rated on a numerical scale (0 = possible without difficulty, 1 = possible with slight difficulty, 2 =possible with great difficulty, and 3 = impossible), being 30 points the worst possible pain score. Change calculated as difference between the month 6 value and baseline value Target hand defined as the patient's most symptomatic hand or, when both hands were equally painful, the patient's dominant hand | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Evaluation on Efficacy | Global impression of the efficacy judged by the Investigators at month 6 by means of a visual analogue scale from 0 (no efficacy) to 100 mm (very good efficacy) | 6 months |
| Change in Grip Strength |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Cem Gabay, Prof. Dr. | HUG - Hôpitaux universitaires de Genève | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7920505 | Background | Lequesne M. [Symptomatic slow-action anti-arthritic agents: a new therapeutic concept?]. Rev Rhum Ed Fr. 1994 Feb;61(2):75-9. No abstract available. French. | |
| 15751094 | Background | Michel BA, Stucki G, Frey D, De Vathaire F, Vignon E, Bruehlmann P, Uebelhart D. Chondroitins 4 and 6 sulfate in osteoarthritis of the knee: a randomized, controlled trial. Arthritis Rheum. 2005 Mar;52(3):779-86. doi: 10.1002/art.20867. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chondroitin 4&6 Sulfate (Condrosulf) | Chondroitin 4&6 sulfate (Condrosulf): 800 mg/day for 6 months |
| FG001 | Placebo | Placebo: 800 mg placebo/day for 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chondroitin 4&6 Sulfate (Condrosulf) | Chondroitin 4&6 sulfate (Condrosulf): 800 mg/day for 6 months |
| BG001 | Placebo | Placebo: 800 mg placebo/day for 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Global Spontaneous Pain Intensity of Target Hand | Intensity of global spontaneous pain is evaluated by the patient himself on a Huskisson's visual analogue scale (VAS) of 100 mm. 0=no pain 100=max pain Change calculated as difference between Month 6 value and baseline value target hand is defined as the patient's most symptomatic hand or, when both hands were equally painful, the patient's dominant hand. | ITT | Posted | Mean | Standard Deviation | mm | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chondroitin 4&6 Sulfate (Condrosulf) | Chondroitin 4&6 sulfate (Condrosulf): 800 mg/day for 6 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Leader | IBSA Institut biochimique | 0041 58360100 | rd@ibsa.ch |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Placebo |
| Other |
800 mg placebo/day for 6 months |
|
Grip strength determined on both hands using a Jamar dynamometer.Patients were required to grip the dynamometer handle and squeeze as hard as possible according to their individual pain limits. The right hand grip was measured first, then the left; this procedure was performed 3 times. The mean value of these 3 measurements was recorded.
Change calculated as difference between the month 6 value and baseline value
| 6 months |
| Change in Morning Stiffness Duration | Change in morning stiffness duration calculated as the difference between the month 6 value and the baseline value | 6 months |
| Consumption of Paracetamol | Total consumption (between ^baseline and month 6) of paracetamol (500 mg tablets) reported by the patients on a daily diary | 6 months |
| 15023378 | Background | Uebelhart D, Malaise M, Marcolongo R, de Vathaire F, Piperno M, Mailleux E, Fioravanti A, Matoso L, Vignon E. Intermittent treatment of knee osteoarthritis with oral chondroitin sulfate: a one-year, randomized, double-blind, multicenter study versus placebo. Osteoarthritis Cartilage. 2004 Apr;12(4):269-76. doi: 10.1016/j.joca.2004.01.004. |
| 7647428 | Background | Cicuttini FM, Spector TD. Osteoarthritis in the aged. Epidemiological issues and optimal management. Drugs Aging. 1995 May;6(5):409-20. doi: 10.2165/00002512-199506050-00007. |
| 8210583 | Background | Howell DS, Altman RD. Cartilage repair and conservation in osteoarthritis. A brief review of some experimental approaches to chondroprotection. Rheum Dis Clin North Am. 1993 Aug;19(3):713-24. |
| 12359162 | Background | Volpi N. Oral bioavailability of chondroitin sulfate (Condrosulf) and its constituents in healthy male volunteers. Osteoarthritis Cartilage. 2002 Oct;10(10):768-77. doi: 10.1053/joca.2002.0824. |
| 1772467 | Background | Conte A, de Bernardi M, Palmieri L, Lualdi P, Mautone G, Ronca G. Metabolic fate of exogenous chondroitin sulfate in man. Arzneimittelforschung. 1991 Jul;41(7):768-72. |
| 8856618 | Background | Morreale P, Manopulo R, Galati M, Boccanera L, Saponati G, Bocchi L. Comparison of the antiinflammatory efficacy of chondroitin sulfate and diclofenac sodium in patients with knee osteoarthritis. J Rheumatol. 1996 Aug;23(8):1385-91. |
| 9743814 | Background | Ronca F, Palmieri L, Panicucci P, Ronca G. Anti-inflammatory activity of chondroitin sulfate. Osteoarthritis Cartilage. 1998 May;6 Suppl A:14-21. doi: 10.1016/s1063-4584(98)80006-x. |
| 9743813 | Background | Uebelhart D, Thonar EJ, Zhang J, Williams JM. Protective effect of exogenous chondroitin 4,6-sulfate in the acute degradation of articular cartilage in the rabbit. Osteoarthritis Cartilage. 1998 May;6 Suppl A:6-13. doi: 10.1016/s1063-4584(98)80005-8. |
| 9743816 | Background | Bourgeois P, Chales G, Dehais J, Delcambre B, Kuntz JL, Rozenberg S. Efficacy and tolerability of chondroitin sulfate 1200 mg/day vs chondroitin sulfate 3 x 400 mg/day vs placebo. Osteoarthritis Cartilage. 1998 May;6 Suppl A:25-30. doi: 10.1016/s1063-4584(98)80008-3. |
| 1485136 | Background | Mazieres B, Loyau G, Menkes CJ, Valat JP, Dreiser RL, Charlot J, Masounabe-Puyanne A. [Chondroitin sulfate in the treatment of gonarthrosis and coxarthrosis. 5-months result of a multicenter double-blind controlled prospective study using placebo]. Rev Rhum Mal Osteoartic. 1992 Jul-Sep;59(7-8):466-72. French. |
| 9743817 | Background | Bucsi L, Poor G. Efficacy and tolerability of oral chondroitin sulfate as a symptomatic slow-acting drug for osteoarthritis (SYSADOA) in the treatment of knee osteoarthritis. Osteoarthritis Cartilage. 1998 May;6 Suppl A:31-6. doi: 10.1016/s1063-4584(98)80009-5. |
| 9743819 | Background | Uebelhart D, Thonar EJ, Delmas PD, Chantraine A, Vignon E. Effects of oral chondroitin sulfate on the progression of knee osteoarthritis: a pilot study. Osteoarthritis Cartilage. 1998 May;6 Suppl A:39-46. doi: 10.1016/s1063-4584(98)80011-3. |
| 9743818 | Background | Verbruggen G, Goemaere S, Veys EM. Chondroitin sulfate: S/DMOAD (structure/disease modifying anti-osteoarthritis drug) in the treatment of finger joint OA. Osteoarthritis Cartilage. 1998 May;6 Suppl A:37-8. doi: 10.1016/s1063-4584(98)80010-1. |
| 12111630 | Background | Verbruggen G, Goemaere S, Veys EM. Systems to assess the progression of finger joint osteoarthritis and the effects of disease modifying osteoarthritis drugs. Clin Rheumatol. 2002 Jun;21(3):231-43. doi: 10.1007/s10067-002-8290-7. |
| 7583182 | Background | Dreiser RL, Maheu E, Guillou GB, Caspard H, Grouin JM. Validation of an algofunctional index for osteoarthritis of the hand. Rev Rhum Engl Ed. 1995 Jun;62(6 Suppl 1):43S-53S. |
| 2242058 | Background | Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Gray R, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hand. Arthritis Rheum. 1990 Nov;33(11):1601-10. doi: 10.1002/art.1780331101. |
| 21898340 | Derived | Gabay C, Medinger-Sadowski C, Gascon D, Kolo F, Finckh A. Symptomatic effects of chondroitin 4 and chondroitin 6 sulfate on hand osteoarthritis: a randomized, double-blind, placebo-controlled clinical trial at a single center. Arthritis Rheum. 2011 Nov;63(11):3383-91. doi: 10.1002/art.30574. |
| Intercurrent illness |
|
| Protocol Violation |
|
| Other reasons |
|
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Switzerland | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Handedness (no. with dominant left/right hand) | Number of patients with dominant left hand / dominant right hand | Number | participants |
|
| Handedness (no. with target left/right hand) | Number of patients with target (more painful) left hand / target (more painful) right hand | Number | participants |
|
| Symptom duration, mean +/- SD (standard deviation) years, left/right hand | Mean | Standard Deviation | years |
|
| No. of painful flares in 12 months, mean +/- SD (standard deviation) | Mean | Standard Deviation | flares |
|
| No. of proximal interphalangeal (PIP) nodal joints, mean +/- SD (standard deviation) left/right hand | Mean | Standard Deviation | number of joints |
|
| No. distal interphalangeal (DIP) nodal joints, mean +/- SD (standard deviation), left/right hand | Mean | Standard Deviation | number of joints |
|
| Patient's assess. of global hand pain, mean +/- SD (standard deviation), left/right/target hand | Pain measured with a Visual Analogue Scale (0-100mm where 0=no pain, 100=maximum pain) | Mean | Standard Deviation | mm |
|
| Functional Index for Hand Osteoarthritis (FIHOA) score, mean +/- SD (standard deviation) | Functional Index for Hand Osteoarthritis (Dreiser's Index). Range 0-30 Patients reported the severity of their symptoms by answering a set of 10 questions. Severity was rated on a numerical scale (0 = possible without difficulty, 1 = possible with slight difficulty, 2 =possible with great difficulty, and 3 = impossible), being 30 points the worst possible pain score | Mean | Standard Deviation | units on a scale |
|
| No. of fingers with osteophytes on PIP joints, mean +/- SD (standard deviation), left/right hand | Mean | Standard Deviation | number of fingers |
|
| No. of fingers with osteophytes on DIP joints, mean +/- SD (standard deviation), left/right hand | Mean | Standard Deviation | number of fingers |
|
| No. of patients with erosive hand OA | Number | participants |
|
| No. of patients with rhizarthrosis | Number | participants |
|
|
|
|
| Primary | Change in Functional Index for Hand Osteoarthritis Dreiser's Score (FIHOA) in the Target Hand | Functional Index for Hand Osteoarthritis (Dreiser's Index). Range 0-30 Patients reported the severity of their symptoms by answering a set of 10 questions. Severity was rated on a numerical scale (0 = possible without difficulty, 1 = possible with slight difficulty, 2 =possible with great difficulty, and 3 = impossible), being 30 points the worst possible pain score. Change calculated as difference between the month 6 value and baseline value Target hand defined as the patient's most symptomatic hand or, when both hands were equally painful, the patient's dominant hand | ITT | Posted | Mean | Standard Deviation | score on a scale | 6 month |
|
|
|
|
| Secondary | Investigator Global Evaluation on Efficacy | Global impression of the efficacy judged by the Investigators at month 6 by means of a visual analogue scale from 0 (no efficacy) to 100 mm (very good efficacy) | ITT (missing values where not replaced) | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| Secondary | Change in Grip Strength | Grip strength determined on both hands using a Jamar dynamometer.Patients were required to grip the dynamometer handle and squeeze as hard as possible according to their individual pain limits. The right hand grip was measured first, then the left; this procedure was performed 3 times. The mean value of these 3 measurements was recorded. Change calculated as difference between the month 6 value and baseline value | ITT (missing values were not replaced) | Posted | Mean | Standard Deviation | Kg/cm^2 | 6 months |
|
|
|
|
| Secondary | Change in Morning Stiffness Duration | Change in morning stiffness duration calculated as the difference between the month 6 value and the baseline value | ITT (missing values were not replaced) | Posted | Mean | Standard Deviation | minutes | 6 months |
|
|
|
|
| Secondary | Consumption of Paracetamol | Total consumption (between ^baseline and month 6) of paracetamol (500 mg tablets) reported by the patients on a daily diary | ITT (missing values were not replaced) | Posted | Mean | Standard Deviation | tablets/week | 6 months |
|
|
|
|
| 0 |
| 81 |
| 2 |
| 81 |
| 5 |
| 81 |
| EG001 | Placebo | Placebo: 800 mg placebo/day for 6 months | 0 | 82 | 2 | 82 | 4 | 82 |
| Anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| pyrexia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| synus tachicardia | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| aortic aneurysm | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
|
| wrist fracture | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
|
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| doubtful improvement of the clinical condition |
|
| no improvement |
|