Trial Outcomes & Findings for Study on Efficacy and Safety of Chondroitin Sulfate + Glucosamine Hydrochloride Versus Celecoxib in Knee Osteoarthritis (NCT NCT01425853)
NCT ID: NCT01425853
Last Updated: 2016-02-26
Results Overview
Western Ontario \& McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 500 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing.
COMPLETED
PHASE4
606 participants
6 months
2016-02-26
Participant Flow
Participant milestones
| Measure |
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)
Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride
|
Celecoxib
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib
|
|---|---|---|
|
Overall Study
STARTED
|
304
|
302
|
|
Overall Study
Safety Population
|
304
|
299
|
|
Overall Study
Per Protocol (PP)
|
264
|
258
|
|
Overall Study
COMPLETED
|
240
|
225
|
|
Overall Study
NOT COMPLETED
|
64
|
77
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study on Efficacy and Safety of Chondroitin Sulfate + Glucosamine Hydrochloride Versus Celecoxib in Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)
n=264 Participants
Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride
|
Celecoxib
n=258 Participants
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib
|
Total
n=522 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.22 Years
STANDARD_DEVIATION 8.81 • n=5 Participants
|
63.16 Years
STANDARD_DEVIATION 9.02 • n=7 Participants
|
62.68 Years
STANDARD_DEVIATION 8.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
229 Participants
n=5 Participants
|
209 Participants
n=7 Participants
|
438 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
WOMAC Pain Subscale
|
371.97 units on a scale
STANDARD_DEVIATION 41.76 • n=5 Participants
|
370.60 units on a scale
STANDARD_DEVIATION 41.15 • n=7 Participants
|
371.29 units on a scale
STANDARD_DEVIATION 41.57 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Imputed data on PP population
Western Ontario \& McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 500 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing.
Outcome measures
| Measure |
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)
n=264 Participants
Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride
|
Celecoxib
n=258 Participants
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib
|
|---|---|---|
|
WOMAC Pain Subscale
|
185.79 units on a scale
Standard Deviation 7.43
|
184.67 units on a scale
Standard Deviation 7.60
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: ADO on PP population
Western Ontario \& McMaster Universities Osteoarthritis Index, from 0 No Stiffness to 200 Maximum Stiffness WOMAC stiffness subscale was used to measure the stiffness of the knee with pain. Two items are used to assess stiffness grade: after first waking and later in the day.
Outcome measures
| Measure |
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)
n=264 Participants
Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride
|
Celecoxib
n=258 Participants
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib
|
|---|---|---|
|
WOMAC Stiffness Subscale
Baseline
|
130.15 units on a scale
Standard Deviation 34.97
|
129.48 units on a scale
Standard Deviation 37.18
|
|
WOMAC Stiffness Subscale
180 days
|
69.06 units on a scale
Standard Deviation 2.92
|
65.78 units on a scale
Standard Deviation 2.99
|
SECONDARY outcome
Timeframe: 6 monthsWestern Ontario \& McMaster Universities Osteoarthritis Index, from 0 No Function to 1700 Maximum Function WOMAC functional limitation subscale was used to measure the functionality of the knee with pain. Seventeen items are used to assess functionality of the knee: tair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties.
Outcome measures
| Measure |
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)
n=264 Participants
Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride
|
Celecoxib
n=258 Participants
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib
|
|---|---|---|
|
WOMAC Function Subscale
Baseline
|
1131.40 units on a scale
Standard Deviation 242.68
|
1111.60 units on a scale
Standard Deviation 267.81
|
|
WOMAC Function Subscale
180 days
|
616.96 units on a scale
Standard Deviation 23.51
|
595.78 units on a scale
Standard Deviation 24.10
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: ADO on PP population
Visual Analogue Scale: 0 No Pain 100 Maximum Pain Huskisson's VAS measures global pain intensity. Patients were asked to quantify their disease status on a 100 mm VAS as follows: "Please indicate the severity of knee pain experienced during the last 48 hours by marking a (I) through the line". Left hand marker represents "No pain" and right hand marker represents "The worst pain imaginable".
Outcome measures
| Measure |
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)
n=264 Participants
Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride
|
Celecoxib
n=258 Participants
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib
|
|---|---|---|
|
Huskisson's VAS
Baseline
|
72.79 units on a scale
Standard Deviation 15.12
|
73.47 units on a scale
Standard Deviation 15.10
|
|
Huskisson's VAS
180 days
|
37.86 units on a scale
Standard Deviation 1.61
|
37.64 units on a scale
Standard Deviation 1.65
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: ADO on PP population
The OARSI Standing Committee for Clinical Trials Response Criteria Initiative and the OMERACT committee, in concert with the international rheumatology community, has led to the development of a uniform core set of outcome measures for OA. One of the objectives was to propose a set of criteria for measurement based on multiple domains to present the results of changes after treatment in symptomatic parameters as a single variable for clinical trials. To be considered as responder patients should met one the following criteria: * High improvement in pain or in function ≥ 50% and absolute change ≥ 20 or * Improvement in at least 2 of the 3 following: * Pain ≥ 20% and absolute change ≥ 10 * Function ≥ 20% and absolute change ≥ 10 * Patient's global assessment ≥ 20% and absolute change ≥ 10
Outcome measures
| Measure |
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)
n=236 Participants
Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride
|
Celecoxib
n=221 Participants
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib
|
|---|---|---|
|
Percentage of Participants With Response as Defined by Outcome Variables for Osteoarthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI)
|
79.7 percentage of participants
|
79.2 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: ADO on PP population
Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion.
Outcome measures
| Measure |
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)
n=236 Participants
Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride
|
Celecoxib
n=221 Participants
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib
|
|---|---|---|
|
Percentage of Presence of Joint Swelling
|
5.9 percentage of participants
|
4.5 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: ADO on PP population
Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion.
Outcome measures
| Measure |
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)
n=236 Participants
Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride
|
Celecoxib
n=221 Participants
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib
|
|---|---|---|
|
Percentage of Presence of Joint Effusion
|
4.1 percentage of participants
|
3.8 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Consumption of rescue medication (number of daily tablets consumed). ADO on PP population. daily tablets consumed/month
Use of rescue medication as number of paracetamol tablets 500 mg since the last visit. The tablet count was reconciled with the patient diary. Total Number of pills per month
Outcome measures
| Measure |
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)
n=264 Participants
Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride
|
Celecoxib
n=258 Participants
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib
|
|---|---|---|
|
Consumption of Rescue Medication
|
31.0 daily tablets consumed/month
Standard Deviation 2.6
|
29.0 daily tablets consumed/month
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Patient and Investigator's global assessment of disease activity. ADO on PP population
Patients were asked to quantify their disease status on a VAS scale with range 0 mm (best) and 100 mm (worst) as follows: "Considering all the ways your arthritis of the knee affects you, mark (I) on the scale how well you are doing." Left hand marker "Very Well", Right hand marked "Very Poor".
Outcome measures
| Measure |
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)
n=264 Participants
Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride
|
Celecoxib
n=258 Participants
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib
|
|---|---|---|
|
Patient's Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity
PGA Activity Baseline
|
69.11 units on a scale
Standard Deviation 17.34
|
69.41 units on a scale
Standard Deviation 16.44
|
|
Patient's Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity
PGA Activity 180 days
|
38.35 units on a scale
Standard Deviation 1.54
|
36.88 units on a scale
Standard Deviation 1.59
|
|
Patient's Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity
IGA Activity Baseline
|
63.2 units on a scale
Standard Deviation 15.54
|
63.28 units on a scale
Standard Deviation 14.71
|
|
Patient's Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity
IGA Activity 180 daus
|
35.33 units on a scale
Standard Deviation 1.39
|
33.40 units on a scale
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Investigator and Patient's global assessment assessment of response to therapy. ADO on PP population.
The investigator were asked to evaluated the patient's response to therapy of the index knee by marking a (I) a VAS scale with range 0 mm (best) and 100 mm (worst) as follows: Left hand marker "Excellent-Best possible anticipated response, considering the severity and stage of the disease", right hand marker "None-no response, absence of drug effect".
Outcome measures
| Measure |
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)
n=264 Participants
Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride
|
Celecoxib
n=258 Participants
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib
|
|---|---|---|
|
Patient's and Investigator's Global Assessment of Response to Therapy
PGA Therapy Baseline
|
54.59 units on a scale
Standard Deviation 1.55
|
45.9 units on a scale
Standard Deviation 1.57
|
|
Patient's and Investigator's Global Assessment of Response to Therapy
PGA Therapy 180 days
|
36.85 units on a scale
Standard Deviation 1.70
|
36.04 units on a scale
Standard Deviation 1.75
|
|
Patient's and Investigator's Global Assessment of Response to Therapy
IGA Therapy Baseline
|
51.4 units on a scale
Standard Deviation 1.43
|
42.25 units on a scale
Standard Deviation 1.45
|
|
Patient's and Investigator's Global Assessment of Response to Therapy
IGA Therapy 180 days
|
34.72 units on a scale
Standard Deviation 1.6
|
33.83 units on a scale
Standard Deviation 1.64
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: ADO on PP population
EuroQoL-5D was a standardized instrument for use as a measure of health outcome that provides a simple descriptive profile and a single index value for health status. It was assessed at all of the study visits. The EQ-5D-3L essentially consists of 2 pages - the EQ-5D descriptive system (page 2) and the EQ visual analogue scale (EQ VAS) (page 3). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. Total scale range for each dimension reported is 1 to 3. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents. Total scale range for VAS dimension reported is 0 to 100.
Outcome measures
| Measure |
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)
n=264 Participants
Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride
|
Celecoxib
n=258 Participants
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib
|
|---|---|---|
|
Health Status According to EuroQoL
Mobility Baseline
|
1.84 points
Standard Deviation 0.37
|
1.84 points
Standard Deviation 0.38
|
|
Health Status According to EuroQoL
Mobility 180 Days
|
1.52 points
Standard Deviation 0.033
|
1.46 points
Standard Deviation 0.034
|
|
Health Status According to EuroQoL
Self-care Baseline
|
1.39 points
Standard Deviation 0.49
|
1.44 points
Standard Deviation 0.5
|
|
Health Status According to EuroQoL
Self-care 180 days
|
1.19 points
Standard Deviation 0.026
|
1.21 points
Standard Deviation 0.027
|
|
Health Status According to EuroQoL
Usual activities Baseline
|
1.78 points
Standard Deviation 0.44
|
1.79 points
Standard Deviation 0.42
|
|
Health Status According to EuroQoL
Usual activities 180 days
|
1.42 points
Standard Deviation 0.033
|
1.42 points
Standard Deviation 0.034
|
|
Health Status According to EuroQoL
Pain Discomfort Baseline
|
2.25 points
Standard Deviation 0.43
|
2.27 points
Standard Deviation 0.45
|
|
Health Status According to EuroQoL
Pain Discomfort 180 days
|
1.84 points
Standard Deviation 0.032
|
1.86 points
Standard Deviation 0.033
|
|
Health Status According to EuroQoL
Anxiety depression baseline
|
1.70 points
Standard Deviation 0.58
|
1.60 points
Standard Deviation 0.58
|
|
Health Status According to EuroQoL
Anxiety depression 180 days
|
1.43 points
Standard Deviation 0.038
|
1.34 points
Standard Deviation 0.035
|
|
Health Status According to EuroQoL
VAS Baseline
|
54.545 points
Standard Deviation 20.33
|
52.488 points
Standard Deviation 20.66
|
|
Health Status According to EuroQoL
VAS 180 days
|
69.080 points
Standard Deviation 1.28
|
70.219 points
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Safety population
The safety evaluation was done in the set of randomized patients who took at least one dose of the medication
Outcome measures
| Measure |
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)
n=304 Participants
Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride
|
Celecoxib
n=299 Participants
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib
|
|---|---|---|
|
Number of Participants With at Least One Adverse Events
|
155 number of participants
|
151 number of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Safety population
The safety evaluation was done in the set of randomized patients who took at least one dose of the medication
Outcome measures
| Measure |
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)
n=304 Participants
Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride
|
Celecoxib
n=299 Participants
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib
|
|---|---|---|
|
Number of Adverse Events Defined by Relationship With Treatment
Treatment-related AEs: Definitive
|
3 number of events
|
10 number of events
|
|
Number of Adverse Events Defined by Relationship With Treatment
Treatment-related AEs: Possibly
|
43 number of events
|
38 number of events
|
|
Number of Adverse Events Defined by Relationship With Treatment
Treatment-related AEs: Probably
|
25 number of events
|
12 number of events
|
|
Number of Adverse Events Defined by Relationship With Treatment
Treatment-related AEs: Non-appraisable
|
0 number of events
|
1 number of events
|
|
Number of Adverse Events Defined by Relationship With Treatment
Treatment-related AEs: unlikely or unrelated
|
84 number of events
|
90 number of events
|
SECONDARY outcome
Timeframe: 6 monthsThe following biomarkers will be evaluated: COMP, Coll2-1, Coll2-1 NO2 and Fib3-2
Outcome measures
Outcome data not reported
Adverse Events
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)
Celecoxib
Serious adverse events
| Measure |
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)
n=304 participants at risk
Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride
|
Celecoxib
n=299 participants at risk
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.33%
1/304
|
0.00%
0/299
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/304
|
0.33%
1/299
|
|
Immune system disorders
Hypersensitivity
|
0.33%
1/304
|
0.00%
0/299
|
|
Infections and infestations
Helicobacter gastritis
|
0.33%
1/304
|
0.00%
0/299
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/304
|
0.33%
1/299
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/304
|
0.33%
1/299
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/304
|
0.33%
1/299
|
|
Nervous system disorders
Dizziness
|
0.00%
0/304
|
0.33%
1/299
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/304
|
0.33%
1/299
|
|
Nervous system disorders
Syncope
|
0.00%
0/304
|
0.33%
1/299
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.33%
1/304
|
0.00%
0/299
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/304
|
0.33%
1/299
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.00%
0/304
|
0.33%
1/299
|
|
Surgical and medical procedures
Carpal tunnel decompression
|
0.33%
1/304
|
0.00%
0/299
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/304
|
0.33%
1/299
|
|
Surgical and medical procedures
Obesity surgery
|
0.33%
1/304
|
0.00%
0/299
|
|
Vascular disorders
Hypertension
|
0.33%
1/304
|
0.00%
0/299
|
Other adverse events
| Measure |
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)
n=304 participants at risk
Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.
Chondroitin sulfate/ Glucosamine hydrochloride
|
Celecoxib
n=299 participants at risk
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Celecoxib
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain upper
|
0.00%
0/304
|
1.0%
3/299 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
0.33%
1/304 • Number of events 1
|
1.0%
3/299 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
0.33%
1/304 • Number of events 1
|
1.0%
3/299 • Number of events 4
|
|
Gastrointestinal disorders
Tootache
|
0.99%
3/304 • Number of events 3
|
1.3%
4/299 • Number of events 4
|
|
Infections and infestations
Bronchitis
|
3.3%
10/304 • Number of events 10
|
2.3%
7/299 • Number of events 7
|
|
Infections and infestations
Cystitis
|
0.33%
1/304 • Number of events 1
|
1.0%
3/299 • Number of events 3
|
|
Infections and infestations
Influenza
|
0.33%
1/304 • Number of events 1
|
1.0%
3/299 • Number of events 3
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
26/304 • Number of events 30
|
7.7%
23/299 • Number of events 26
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/304
|
1.3%
4/299 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
10/304 • Number of events 11
|
2.0%
6/299 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.6%
20/304 • Number of events 27
|
3.0%
9/299 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.33%
1/304 • Number of events 1
|
1.3%
4/299 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
1.3%
4/304 • Number of events 5
|
1.0%
3/299 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
10/304 • Number of events 10
|
0.67%
2/299 • Number of events 3
|
|
Nervous system disorders
Headache
|
8.2%
25/304 • Number of events 56
|
10.4%
31/299 • Number of events 93
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.99%
3/304 • Number of events 3
|
0.33%
1/299 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.99%
3/304 • Number of events 4
|
1.0%
3/299 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place