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The main purpose of this study is to evaluate how a long-term treatment with Theraflex during 64 weeks affects pain intensity in the affected knee or hip joint, the activity in daily living, the quality of life and patient satisfaction with treatment.
Other information that is planned for evaluation in this study includes consumption of Theraflex, intake of analgesics for joint pain relief and description of basic patient characteristics such as age, weight and body mass index and others.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Stage I-III Knee osteoarthritis (KOA) | Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment |
| |
| Participants with Stage I-III Hip osteoarthritis (HOA) | Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theraflex, BAY 874017 | Drug | The first three weeks which do have a different posology (3 capsules a day) according to the label should be entered as a distinct period to the treatment period with a recommended posology of 2 capsules a day |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Pain Intensity Subscale | KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Pain intensity is one subscale of KOOS and HOOS questionnaire, each pain intensity question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS pain intensity subscale were calculated as [100 - (mean value of all subscale questions * 100) / 4]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS pain intensity subscale results calculation used a similar method. | From enrollment up to 64 weeks |
| Changes in Other Symptoms Subscale | KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Other symptoms is one subscale of KOOS and HOOS questionnaire, each other symptoms question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS other symptoms subscale were calculated as [100 - (mean value of all subscale questions * 100) / 4]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS other symptoms subscale results calculation used a similar method. | From enrollment up to 64 weeks |
| Change in Functional Activity of the Joint Subscale | KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Functional activity is one subscale of KOOS and HOOS questionnaire, each functional activity question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS functional activity subscale were calculated by converting value of all subscale questions to KOOS-Physical Short form score. Results score is from 0 to 100, 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS functional activity subscale results used a similar method with HOOS-Physical Short form. | From enrollment up to 64 weeks |
| Change in Life Quality Subscale | KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Life quality is one subscale of KOOS and HOOS questionnaire, each life quality question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS life quality subscale were calculated as [100 - (mean value of all subscale questions * 100) / 4]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS life quality subscale results calculation used a similar method. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participant Compliance With Drug Utilization of Theraflex | Drug utilization of Theraflex as reported by the patient to their physician. Administration duration categories are: 1.patients receiving Theraflex up to 1 month inclusive; 2.patients taking Theraflex during 1 to 3 months; 3.patients taking Theraflex during 3 to 6 months; 4. patients taking Theraflex during more than 6 months. Investigators assessed compliance with the recommendations for the duration of Theraflex. |
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Inclusion Criteria:
Exclusion Criteria:
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Patient who will be made aware about the study either by the treating physician OR by a pharmacist where a patient is purchasing Theraflex
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sci-Res Institute of Rheumatology n.a. V.A. Nasonova of RAMS | Moscow | 115522 | Russia | |||
| Many locations |
A total of 1111 participants were screened over the course of the study, of which 1102 participants were enrolled in the study. Among them, 824 participants were diagnosed with knee osteoarthritis (KOA), while 278 participants were diagnosed with hip osteoarthritis (HOA).
Study was conducted at 51 centers in Russian Federation, between 20-Nov-2017 (first participant first visit) and 13-Jul-2020 (Database clean). The Primary Completion date is 18-Mar-2020 (last participant last visit)
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Stage I-III Knee Osteoarthritis (KOA) | Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment |
| FG001 | Participants With Stage I-III Hip Osteoarthritis (HOA) | Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Stage I-III Knee Osteoarthritis (KOA) | Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment |
| BG001 | Participants With Stage I-III Hip Osteoarthritis (HOA) |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Changes in the Pain Intensity Subscale | KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Pain intensity is one subscale of KOOS and HOOS questionnaire, each pain intensity question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS pain intensity subscale were calculated as [100 - (mean value of all subscale questions * 100) / 4]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS pain intensity subscale results calculation used a similar method. | The outcome measure was analyzed based on participants who has KOOS/HOOS assessment. | Posted | Mean | Standard Deviation | Scores on a scale | From enrollment up to 64 weeks |
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After initial administration of Theraflex up to 64 weeks.
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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 | Participants With Stage I-III Hip Osteoarthritis (HOA) | Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | (+) 1-888-8422937 | clinical-trials-contact@bayer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 4, 2018 | Jun 15, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 13, 2020 | Jun 15, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| From enrollment up to 64 weeks |
| From enrollment up to 64 weeks |
| Change in Patient Satisfaction Assessment | Patient satisfaction questionnaire was filled out during the visit to a doctor. A patient assessed treatment satisfaction against the Likert response scale : 5-very satisfied, 4-Satisfied, 3- No answer, 2-Dissatisfied, 1-very dissatisfied | From enrollment up to 64 weeks |
| Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA) | Concomitant therapy of the target joint osteoarthritis (OA) by choosing any of the following categories: 'Symptomatic therapy with analgesics for the target joint OA', 'Other drug treatment for pain syndrome of the target joint OA', 'Other therapy for the target joint OA'. | From enrollment up to 64 weeks |
| Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA) Used After the Completion of Treatment With Theraflex | Concomitant therapy of the target joint osteoarthritis (OA) by choosing any of the following categories: 'Symptomatic therapy with analgesics for the target joint OA', 'Other drug treatment for pain syndrome of the target joint OA', 'Other therapy for the target joint OA'. | From enrollment up to 64 weeks |
| Multiple Locations |
| Russia |
| Adverse Event |
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| Withdrawal by Subject |
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| Lost to Follow-up |
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Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Pain intensity subscale | KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Pain intensity is one subscale of KOOS and HOOS questionnaire, each pain intensity question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS pain intensity subscale were calculated as [100 - (mean value of all subscale questions * 100) / 4]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS pain intensity subscale results calculation used a similar method. | KOA patients and HOA patients are reported separately for each Arm of the study | Mean | Standard Deviation | Scores on a scale |
|
| Other symptom subscale | KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Other symptoms is one subscale of KOOS and HOOS questionnaire, each other symptoms question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS other symptoms subscale were calculated as [100 - (mean value of all subscale questions * 100) / 4]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS other symptoms subscale results calculation used a similar method. | KOA patients and HOA patients are reported separately for each Arm of the study | Mean | Standard Deviation | Scores on a scale |
|
| Functional activity of the joint subscale | KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Functional activity is one subscale of KOOS and HOOS questionnaire, each functional activity question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS functional activity subscale were calculated by converting value of all subscale questions to KOOS-Physical Short form score. Results score is from 0 to 100, 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS functional activity subscale results used a similar method with HOOS-Physical Short form. | KOA patients and HOA patients are reported separately for each Arm of the study | Mean | Standard Deviation | Scores on a scale |
|
| Life quality subscale | KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Life quality is one subscale of KOOS and HOOS questionnaire, each life quality question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS life quality subscale were calculated as [100 - (mean value of all subscale questions * 100) / 4]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS life quality subscale results calculation used a similar method. | KOA patients and HOA patients are reported separately for each Arm of the study | Mean | Standard Deviation | Scores on a scale |
|
| Patient satisfaction assessment | Patient satisfaction questionnaire was filled out during the visit to a doctor. A patient assessed treatment satisfaction against the Likert response scale : 5-very satisfied, 4-Satisfied, 3- No answer, 2-Dissatisfied, 1-very dissatisfied | Mean | Standard Deviation | Scores on a scale |
|
| OG001 | Participants With Stage I-III Hip Osteoarthritis (HOA) | Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment |
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| Primary | Changes in Other Symptoms Subscale | KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Other symptoms is one subscale of KOOS and HOOS questionnaire, each other symptoms question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS other symptoms subscale were calculated as [100 - (mean value of all subscale questions * 100) / 4]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS other symptoms subscale results calculation used a similar method. | The outcome measure was analyzed based on participants who has KOOS/HOOS assessment. | Posted | Mean | Standard Deviation | Scores on a scale | From enrollment up to 64 weeks |
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| Primary | Change in Functional Activity of the Joint Subscale | KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Functional activity is one subscale of KOOS and HOOS questionnaire, each functional activity question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS functional activity subscale were calculated by converting value of all subscale questions to KOOS-Physical Short form score. Results score is from 0 to 100, 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS functional activity subscale results used a similar method with HOOS-Physical Short form. | The outcome measure was analyzed based on participants who has KOOS/HOOS assessment. | Posted | Mean | Standard Deviation | Scores on a scale | From enrollment up to 64 weeks |
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| Primary | Change in Life Quality Subscale | KOA patients used KOOS questionnaire, HOA patients used HOOS questionnaire. Life quality is one subscale of KOOS and HOOS questionnaire, each life quality question provides standard answer options: 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Extreme. The results for KOOS life quality subscale were calculated as [100 - (mean value of all subscale questions * 100) / 4]. Results score is from 0 to 100. 100 indicating no symptoms and 0 indicating extreme symptoms. HOOS life quality subscale results calculation used a similar method. | The outcome measure was analyzed based on participants who has KOOS/HOOS assessment. | Posted | Mean | Standard Deviation | Scores on a scale | From enrollment up to 64 weeks |
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| Secondary | Number of Participant Compliance With Drug Utilization of Theraflex | Drug utilization of Theraflex as reported by the patient to their physician. Administration duration categories are: 1.patients receiving Theraflex up to 1 month inclusive; 2.patients taking Theraflex during 1 to 3 months; 3.patients taking Theraflex during 3 to 6 months; 4. patients taking Theraflex during more than 6 months. Investigators assessed compliance with the recommendations for the duration of Theraflex. | Posted | Number | Participant | From enrollment up to 64 weeks |
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| Secondary | Change in Patient Satisfaction Assessment | Patient satisfaction questionnaire was filled out during the visit to a doctor. A patient assessed treatment satisfaction against the Likert response scale : 5-very satisfied, 4-Satisfied, 3- No answer, 2-Dissatisfied, 1-very dissatisfied | The outcome measure was analyzed based on participants who has KOOS/HOOS assessment. | Posted | Mean | Standard Deviation | Scores on a scale | From enrollment up to 64 weeks |
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| Secondary | Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA) | Concomitant therapy of the target joint osteoarthritis (OA) by choosing any of the following categories: 'Symptomatic therapy with analgesics for the target joint OA', 'Other drug treatment for pain syndrome of the target joint OA', 'Other therapy for the target joint OA'. | Posted | Number | Participant | From enrollment up to 64 weeks |
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| Secondary | Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA) Used After the Completion of Treatment With Theraflex | Concomitant therapy of the target joint osteoarthritis (OA) by choosing any of the following categories: 'Symptomatic therapy with analgesics for the target joint OA', 'Other drug treatment for pain syndrome of the target joint OA', 'Other therapy for the target joint OA'. | Posted | Number | Participant | From enrollment up to 64 weeks |
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| 0 |
| 278 |
| 6 |
| 278 |
| 28 |
| 278 |
| EG001 | Participants With Stage I-III Knee Osteoarthritis (KOA) | Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment | 1 | 824 | 8 | 824 | 55 | 824 |
| Atrial fibrillation | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA (21.1) | Non-systematic Assessment |
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| Myositis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Radicular pain | Nervous system disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Cholecystectomy | Surgical and medical procedures | MedDRA (21.1) | Non-systematic Assessment |
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| Coronary artery bypass | Surgical and medical procedures | MedDRA (21.1) | Non-systematic Assessment |
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| Hip arthroplasty | Surgical and medical procedures | MedDRA (21.1) | Non-systematic Assessment |
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| Knee arthroplasty | Surgical and medical procedures | MedDRA (21.1) | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA (21.1) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (21.1) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (21.1) | Non-systematic Assessment |
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| From Visit 1(enrollment) toVisit 3 (Week 36-44) |
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| From Visit 1(enrollment) toVisit 4 (Week 56-64) |
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| From Visit 1(enrollment) to Visit 3 (Week 36-44) |
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| From Visit 1(enrollment) to Visit 4 (Week 56-64) |
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| From Visit 1(enrollment) to Visit 3 (Week 36-44) |
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| From Visit 1(enrollment) to Visit 4 (Week 56-64) |
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| No data available |
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| From Visit 1(enrollment) to Visit 3 (Week 36-44) |
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| From Visit 1(enrollment) to Visit 4 (Week 56-64) |
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| Other therapy for the target joint OA |
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| Other therapy for the target joint OA |
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