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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024010-61 | EudraCT Number |
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The purpose of this study is to determine whether the combination of Chondroitin sulfate (CS) and Glucosamine Hydrochloride (GH) has similar efficacy to Celecoxib (CE) in the treatment of patients with moderate to severe knee osteoarthritis (OA).
The primary objective of this study is to show that the combination treatment CS/GH has comparable efficacy to CE in pain reduction from baseline to 6 months of treatment measured with the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale in knee OA patients with moderate to severe pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chondroitin/Glucosamine (Droglican) | Experimental | 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. |
|
| Celecoxib | Active Comparator | Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chondroitin/Glucosamine (Droglican) | Drug | Experimental |
|
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC Pain Subscale | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC Stiffness Subscale | 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordi Monfort, MD | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Madrid | Madrid | 28046 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25589511 | Derived | Hochberg MC, Martel-Pelletier J, Monfort J, Moller I, Castillo JR, Arden N, Berenbaum F, Blanco FJ, Conaghan PG, Domenech G, Henrotin Y, Pap T, Richette P, Sawitzke A, du Souich P, Pelletier JP; MOVES Investigation Group. Combined chondroitin sulfate and glucosamine for painful knee osteoarthritis: a multicentre, randomised, double-blind, non-inferiority trial versus celecoxib. Ann Rheum Dis. 2016 Jan;75(1):37-44. doi: 10.1136/annrheumdis-2014-206792. Epub 2015 Jan 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Celecoxib | Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH. Celecoxib |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
PP population was defined as all randomized patients who met the inclusion criteria, received study medication, had a baseline efficacy measurement and at least one corresponding post-baseline efficacy measurement (for the main efficacy variable) and did not present major violations of the protocol (n=522).
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| ID | Title | Description |
|---|---|---|
| BG000 | Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican) | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | WOMAC Pain Subscale | 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. | Imputed data on PP population | Posted | Mean | Standard Deviation | units on a scale | 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 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical R&D Manager | Bioiberica | +34934904908 | mherrero@bioiberica.com |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002807 | Chondroitin |
| D005944 | Glucosamine |
| D002809 | Chondroitin Sulfates |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D006595 | Hexosamines |
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| Celecoxib | Drug | Active comparator |
|
| WOMAC Function Subscale |
Western 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. |
| 6 months |
| Huskisson's VAS | 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". | 6 months |
| Percentage of Participants With Response as Defined by Outcome Variables for Osteoarthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) | 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:
| 6 months |
| Percentage of Presence of Joint Swelling | Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion. | 6 months |
| Percentage of Presence of Joint Effusion | Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion. | 6 months |
| Consumption of Rescue Medication | 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 | 6 months |
| Patient's Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity | 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". | 6 months |
| Patient's and Investigator's Global Assessment of Response to Therapy | 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". | 6 months |
| Health Status According to EuroQoL | 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. | 6 months |
| Number of Participants With at Least One Adverse Events | The safety evaluation was done in the set of randomized patients who took at least one dose of the medication | 6 months |
| Number of Adverse Events Defined by Relationship With Treatment | The safety evaluation was done in the set of randomized patients who took at least one dose of the medication | 6 months |
| Biomarker Analysis | The following biomarkers will be evaluated: COMP, Coll2-1, Coll2-1 NO2 and Fib3-2 | 6 months |
| Celecoxib |
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH. Celecoxib |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| WOMAC Pain Subscale | Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Pain to 500 Maximum Pain | Mean | Standard Deviation | units on a scale |
|
| OG001 | Celecoxib | Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH. Celecoxib |
|
|
| Secondary | WOMAC Stiffness Subscale | 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. | ADO on PP population | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | WOMAC Function Subscale | Western 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Huskisson's VAS | 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". | ADO on PP population | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Percentage of Participants With Response as Defined by Outcome Variables for Osteoarthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) | 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:
| ADO on PP population | Posted | Number | percentage of participants | 6 months |
|
|
|
| Secondary | Percentage of Presence of Joint Swelling | Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion. | ADO on PP population | Posted | Number | percentage of participants | 6 months |
|
|
|
| Secondary | Percentage of Presence of Joint Effusion | Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion. | ADO on PP population | Posted | Number | percentage of participants | 6 months |
|
|
|
| Secondary | Consumption of Rescue Medication | 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 | Consumption of rescue medication (number of daily tablets consumed). ADO on PP population. daily tablets consumed/month | Posted | Mean | Standard Deviation | daily tablets consumed/month | 6 months |
|
|
|
| Secondary | Patient's Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity | 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". | Patient and Investigator's global assessment of disease activity. ADO on PP population | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Patient's and Investigator's Global Assessment of Response to Therapy | 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". | Investigator and Patient's global assessment assessment of response to therapy. ADO on PP population. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Health Status According to EuroQoL | 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. | ADO on PP population | Posted | Mean | Standard Deviation | points | 6 months |
|
|
|
| Secondary | Number of Participants With at Least One Adverse Events | The safety evaluation was done in the set of randomized patients who took at least one dose of the medication | Safety population | Posted | Number | number of participants | 6 months |
|
|
|
| Secondary | Number of Adverse Events Defined by Relationship With Treatment | The safety evaluation was done in the set of randomized patients who took at least one dose of the medication | Safety population | Posted | Number | number of events | 6 months |
|
|
|
| Secondary | Biomarker Analysis | The following biomarkers will be evaluated: COMP, Coll2-1, Coll2-1 NO2 and Fib3-2 | Not Posted | 6 months |
| 7 |
| 304 |
| 119 |
| 304 |
| EG001 | Celecoxib | Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH. Celecoxib | 10 | 299 | 112 | 299 |
| Haematochezia | Gastrointestinal disorders | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | Systematic Assessment |
|
| Helicobacter gastritis | Infections and infestations | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Carpal tunnel decompression | Surgical and medical procedures | Systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | Systematic Assessment |
|
| Obesity surgery | Surgical and medical procedures | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Tootache | Gastrointestinal disorders | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Cystitis | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D012216 |
| Rheumatic Diseases |
| D000606 |
| Amino Sugars |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| IGA Activity Baseline |
|
| IGA Activity 180 daus |
|
| IGA Therapy Baseline |
|
| IGA Therapy 180 days |
|
| Self-care Baseline |
|
| Self-care 180 days |
|
| Usual activities Baseline |
|
| Usual activities 180 days |
|
| Pain Discomfort Baseline |
|
| Pain Discomfort 180 days |
|
| Anxiety depression baseline |
|
| Anxiety depression 180 days |
|
| VAS Baseline |
|
| VAS 180 days |
|
| Treatment-related AEs: Probably |
|
| Treatment-related AEs: Non-appraisable |
|
| Treatment-related AEs: unlikely or unrelated |
|