Trial Outcomes & Findings for Efficacy Study of Condrosulf in the Treatment of Symptomatic OA of the Hand (NCT NCT00291499)
NCT ID: NCT00291499
Last Updated: 2021-03-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
163 participants
Primary outcome timeframe
6 months
Results posted on
2021-03-04
Participant Flow
Participant milestones
| Measure |
Chondroitin 4&6 Sulfate (Condrosulf)
Chondroitin 4\&6 sulfate (Condrosulf): 800 mg/day for 6 months
|
Placebo
Placebo: 800 mg placebo/day for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
82
|
|
Overall Study
Intention to Treat (ITT)
|
80
|
82
|
|
Overall Study
Per Protocol (PP)
|
72
|
67
|
|
Overall Study
Safety Population
|
81
|
82
|
|
Overall Study
COMPLETED
|
72
|
67
|
|
Overall Study
NOT COMPLETED
|
9
|
15
|
Reasons for withdrawal
| Measure |
Chondroitin 4&6 Sulfate (Condrosulf)
Chondroitin 4\&6 sulfate (Condrosulf): 800 mg/day for 6 months
|
Placebo
Placebo: 800 mg placebo/day for 6 months
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
8
|
|
Overall Study
Change to other therapy
|
2
|
1
|
|
Overall Study
Intercurrent illness
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Other reasons
|
1
|
4
|
Baseline Characteristics
Efficacy Study of Condrosulf in the Treatment of Symptomatic OA of the Hand
Baseline characteristics by cohort
| Measure |
Chondroitin 4&6 Sulfate (Condrosulf)
n=80 Participants
Chondroitin 4\&6 sulfate (Condrosulf): 800 mg/day for 6 months
|
Placebo
n=82 Participants
Placebo: 800 mg placebo/day for 6 months
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
63.5 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
80 participants
n=5 Participants
|
82 participants
n=7 Participants
|
162 participants
n=5 Participants
|
|
BMI
|
26.7 kg/m^2
STANDARD_DEVIATION 4.5 • n=5 Participants
|
25.0 kg/m^2
STANDARD_DEVIATION 3.8 • n=7 Participants
|
25.9 kg/m^2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Handedness (no. with dominant left/right hand)
left hand
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Handedness (no. with dominant left/right hand)
right hand
|
55 participants
n=5 Participants
|
56 participants
n=7 Participants
|
111 participants
n=5 Participants
|
|
Handedness (no. with target left/right hand)
left hand
|
23 participants
n=5 Participants
|
27 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Handedness (no. with target left/right hand)
right hand
|
57 participants
n=5 Participants
|
55 participants
n=7 Participants
|
112 participants
n=5 Participants
|
|
Symptom duration, mean +/- SD (standard deviation) years, left/right hand
left hand
|
6.9 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
6.2 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
6.5 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Symptom duration, mean +/- SD (standard deviation) years, left/right hand
right hand
|
7.1 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
6.7 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
6.9 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
No. of painful flares in 12 months, mean +/- SD (standard deviation)
|
35.2 flares
STANDARD_DEVIATION 80.0 • n=5 Participants
|
30.0 flares
STANDARD_DEVIATION 70.3 • n=7 Participants
|
32.6 flares
STANDARD_DEVIATION 75.1 • n=5 Participants
|
|
No. of proximal interphalangeal (PIP) nodal joints, mean +/- SD (standard deviation) left/right hand
left hand
|
1.0 number of joints
STANDARD_DEVIATION 1.5 • n=5 Participants
|
0.9 number of joints
STANDARD_DEVIATION 1.2 • n=7 Participants
|
0.9 number of joints
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
No. of proximal interphalangeal (PIP) nodal joints, mean +/- SD (standard deviation) left/right hand
right hand
|
1.2 number of joints
STANDARD_DEVIATION 1.6 • n=5 Participants
|
1.0 number of joints
STANDARD_DEVIATION 1.2 • n=7 Participants
|
1.0 number of joints
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
No. distal interphalangeal (DIP) nodal joints, mean +/- SD (standard deviation), left/right hand
left hand
|
2.1 number of joints
STANDARD_DEVIATION 1.4 • n=5 Participants
|
2.0 number of joints
STANDARD_DEVIATION 1.4 • n=7 Participants
|
2.1 number of joints
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
No. distal interphalangeal (DIP) nodal joints, mean +/- SD (standard deviation), left/right hand
right hand
|
2.4 number of joints
STANDARD_DEVIATION 1.3 • n=5 Participants
|
2.1 number of joints
STANDARD_DEVIATION 1.4 • n=7 Participants
|
2.2 number of joints
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Patient's assess. of global hand pain, mean +/- SD (standard deviation), left/right/target hand
left hand
|
43.8 mm
STANDARD_DEVIATION 21.0 • n=5 Participants
|
42.4 mm
STANDARD_DEVIATION 21.4 • n=7 Participants
|
43.1 mm
STANDARD_DEVIATION 21.2 • n=5 Participants
|
|
Patient's assess. of global hand pain, mean +/- SD (standard deviation), left/right/target hand
right hand
|
48.7 mm
STANDARD_DEVIATION 19.3 • n=5 Participants
|
45.9 mm
STANDARD_DEVIATION 19.2 • n=7 Participants
|
47.3 mm
STANDARD_DEVIATION 19.2 • n=5 Participants
|
|
Patient's assess. of global hand pain, mean +/- SD (standard deviation), left/right/target hand
target hand
|
54.9 mm
STANDARD_DEVIATION 14.2 • n=5 Participants
|
53.6 mm
STANDARD_DEVIATION 14.2 • n=7 Participants
|
54.2 mm
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Functional Index for Hand Osteoarthritis (FIHOA) score, mean +/- SD (standard deviation)
|
11.0 units on a scale
STANDARD_DEVIATION 4.2 • n=5 Participants
|
10.3 units on a scale
STANDARD_DEVIATION 3.8 • n=7 Participants
|
10.7 units on a scale
STANDARD_DEVIATION 4 • n=5 Participants
|
|
No. of fingers with osteophytes on PIP joints, mean +/- SD (standard deviation), left/right hand
left hand
|
1.9 number of fingers
STANDARD_DEVIATION 1.6 • n=5 Participants
|
1.9 number of fingers
STANDARD_DEVIATION 1.5 • n=7 Participants
|
1.9 number of fingers
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
No. of fingers with osteophytes on PIP joints, mean +/- SD (standard deviation), left/right hand
right hand
|
2.3 number of fingers
STANDARD_DEVIATION 1.5 • n=5 Participants
|
1.9 number of fingers
STANDARD_DEVIATION 1.5 • n=7 Participants
|
2.1 number of fingers
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
No. of fingers with osteophytes on DIP joints, mean +/- SD (standard deviation), left/right hand
left hand
|
2.9 number of fingers
STANDARD_DEVIATION 1.3 • n=5 Participants
|
3.0 number of fingers
STANDARD_DEVIATION 1.2 • n=7 Participants
|
3.0 number of fingers
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
No. of fingers with osteophytes on DIP joints, mean +/- SD (standard deviation), left/right hand
right hand
|
3.1 number of fingers
STANDARD_DEVIATION 1.3 • n=5 Participants
|
3.1 number of fingers
STANDARD_DEVIATION 1.1 • n=7 Participants
|
3.1 number of fingers
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
No. of patients with erosive hand OA
|
26 participants
n=5 Participants
|
35 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
No. of patients with rhizarthrosis
|
37 participants
n=5 Participants
|
43 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: ITT
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.
Outcome measures
| Measure |
Chondroitin 4&6 Sulfate (Condrosulf)
n=80 Participants
Chondroitin 4\&6 sulfate (Condrosulf): 800 mg/day for 6 months
|
Placebo
n=82 Participants
Placebo: 800 mg placebo/day for 6 months
|
|---|---|---|
|
Change in Global Spontaneous Pain Intensity of Target Hand
|
-20 mm
Standard Deviation 26
|
-11.3 mm
Standard Deviation 24
|
PRIMARY outcome
Timeframe: 6 monthPopulation: ITT
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
Outcome measures
| Measure |
Chondroitin 4&6 Sulfate (Condrosulf)
n=80 Participants
Chondroitin 4\&6 sulfate (Condrosulf): 800 mg/day for 6 months
|
Placebo
n=82 Participants
Placebo: 800 mg placebo/day for 6 months
|
|---|---|---|
|
Change in Functional Index for Hand Osteoarthritis Dreiser's Score (FIHOA) in the Target Hand
|
-2.9 score on a scale
Standard Deviation 5.3
|
-0.7 score on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: ITT (missing values where not replaced)
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)
Outcome measures
| Measure |
Chondroitin 4&6 Sulfate (Condrosulf)
n=79 Participants
Chondroitin 4\&6 sulfate (Condrosulf): 800 mg/day for 6 months
|
Placebo
n=76 Participants
Placebo: 800 mg placebo/day for 6 months
|
|---|---|---|
|
Investigator Global Evaluation on Efficacy
marked improvement of the clinical condition
|
15 Participants
|
9 Participants
|
|
Investigator Global Evaluation on Efficacy
slight improvement of the clinical condition
|
20 Participants
|
16 Participants
|
|
Investigator Global Evaluation on Efficacy
doubtful improvement of the clinical condition
|
16 Participants
|
10 Participants
|
|
Investigator Global Evaluation on Efficacy
no improvement
|
28 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: ITT (missing values were not replaced)
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
Outcome measures
| Measure |
Chondroitin 4&6 Sulfate (Condrosulf)
n=70 Participants
Chondroitin 4\&6 sulfate (Condrosulf): 800 mg/day for 6 months
|
Placebo
n=68 Participants
Placebo: 800 mg placebo/day for 6 months
|
|---|---|---|
|
Change in Grip Strength
|
2.5 Kg/cm^2
Standard Deviation 6.6
|
0.6 Kg/cm^2
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: ITT (missing values were not replaced)
Change in morning stiffness duration calculated as the difference between the month 6 value and the baseline value
Outcome measures
| Measure |
Chondroitin 4&6 Sulfate (Condrosulf)
n=72 Participants
Chondroitin 4\&6 sulfate (Condrosulf): 800 mg/day for 6 months
|
Placebo
n=67 Participants
Placebo: 800 mg placebo/day for 6 months
|
|---|---|---|
|
Change in Morning Stiffness Duration
|
-4.8 minutes
Standard Deviation 16.6
|
0.3 minutes
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: ITT (missing values were not replaced)
Total consumption (between \^baseline and month 6) of paracetamol (500 mg tablets) reported by the patients on a daily diary
Outcome measures
| Measure |
Chondroitin 4&6 Sulfate (Condrosulf)
n=78 Participants
Chondroitin 4\&6 sulfate (Condrosulf): 800 mg/day for 6 months
|
Placebo
n=76 Participants
Placebo: 800 mg placebo/day for 6 months
|
|---|---|---|
|
Consumption of Paracetamol
|
1.9 tablets/week
Standard Deviation 2.8
|
2.0 tablets/week
Standard Deviation 4.2
|
Adverse Events
Chondroitin 4&6 Sulfate (Condrosulf)
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chondroitin 4&6 Sulfate (Condrosulf)
n=81 participants at risk
Chondroitin 4\&6 sulfate (Condrosulf): 800 mg/day for 6 months
|
Placebo
n=82 participants at risk
Placebo: 800 mg placebo/day for 6 months
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
1.2%
1/81 • Number of events 1 • 6 months
|
0.00%
0/82 • 6 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/81 • 6 months
|
1.2%
1/82 • Number of events 1 • 6 months
|
|
General disorders
pyrexia
|
0.00%
0/81 • 6 months
|
1.2%
1/82 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/81 • 6 months
|
1.2%
1/82 • Number of events 1 • 6 months
|
|
Cardiac disorders
synus tachicardia
|
0.00%
0/81 • 6 months
|
1.2%
1/82 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/81 • 6 months
|
1.2%
1/82 • Number of events 1 • 6 months
|
|
Vascular disorders
aortic aneurysm
|
0.00%
0/81 • 6 months
|
1.2%
1/82 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.00%
0/81 • 6 months
|
1.2%
1/82 • Number of events 1 • 6 months
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/81 • 6 months
|
1.2%
1/82 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
wrist fracture
|
1.2%
1/81 • Number of events 1 • 6 months
|
0.00%
0/82 • 6 months
|
Other adverse events
| Measure |
Chondroitin 4&6 Sulfate (Condrosulf)
n=81 participants at risk
Chondroitin 4\&6 sulfate (Condrosulf): 800 mg/day for 6 months
|
Placebo
n=82 participants at risk
Placebo: 800 mg placebo/day for 6 months
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
5/81 • 6 months
|
4.9%
4/82 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place