OsteoarthritisNCT03330288
Prospective Multicenter Non-interventional Study in Patients With Knee or Hip Osteoarthritis Having a Theraflex Treatment
An observational study of Osteoarthritis, run by Bayer at 2 sites in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Theraflex, BAY 874017
- Type of treatment
- Pill or oral medicine
- How many people
- 1,102 participants
- Where
- 2 sitesRussia
- Study dates
- 20 Nov 2017to 13 Jul 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who will be made aware about the study either by the treating physician OR by a pharmacist where a patient is purchasing Theraflex
Who may be able to join
- Patients 45 to 75 years with Hip or Knee OA stage I to III
- Patient started current treatment with Theraflex not more than 2 weeks prior to inclusion into the study
- Personally signed and dated informed consent
Who cannot join
- Patients participating in an investigational program with interventions outside of routine clinical practice
- Patients with Hip or Knee OA stage 0 or stage IV
- Patients who have both Hip and Knee OA and OA of any other location
- Contraindications for use of Theraflex in accordance with approved label(known hypersensitivity, severe chronic renal failure)
- Females who are pregnant or breastfeeding
- Patients who completed a treatment with Theraflex or another combination of Gl+ Ch less than 5 months before start of the current treatment
- Patients who completed intra-articular corticosteroids treatment in the last 3 months to exclusion criteria
- Patients who completed hyaluronic injections of the lower limbs in the last 6 months
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Sci-Res Institute of Rheumatology n.a. V.A. Nasonova of RAMS
Moscow, 115522
Many locations
Multiple Locations
About this study
Official title: Prospective Multicenter Non-interventional Study in Patients With Knee or Hip Osteoarthritis Having a Theraflex® Treatment to Evaluate Changes in Pain, Functions in Daily Living, and Quality of Life for an Observation Period up to 64 Weeks
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.
Read the detailed description
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.
- Conditions
- Osteoarthritis
- Being tested
- Theraflex, BAY 874017
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theraflex, BAY 874017Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Participants with Stage I-III Knee osteoarthritis (KOA) | Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment Receives: Drug: Theraflex, BAY 874017 | |
| Participants with Stage I-III Hip osteoarthritis (HOA) | Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment Receives: Drug: Theraflex, BAY 874017 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment up to 64 weeks
Secondary outcomes (4)
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.
Measured: 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
Measured: 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'.
Measured: 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'.
Measured: From enrollment up to 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start20 Nov 2017
- Primary completion18 Mar 2020
- Study completion13 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330288
- Sponsor's protocol ID
- 19649
- Status last verified
- Sep 2021
- First submitted
- 6 Oct 2017
- Last updated
- 14 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Non-interventional Study in Patients With Knee or Hip Osteoarthritis Having a Theraflex® Treatment to Evaluate Changes in Pain, Functions in Daily Living, and Quality of Life for an Observation Period up to 64 Weeks
- ClinicalTrials.gov ID
- NCT03330288
- Acronym / sponsor ID
- 19649
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,102 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Posted 14 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Stage I-III Knee osteoarthritis (KOA) | – | Drug: Theraflex, BAY 874017Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment |
| Participants with Stage I-III Hip osteoarthritis (HOA) | – | Drug: Theraflex, BAY 874017Participants were receiving Theraflex not earlier than 2 weeks prior to enrollment |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who will be made aware about the study either by the treating physician OR by a pharmacist where a patient is purchasing Theraflex
Key inclusion criteria (3 listed)
- Patients 45 to 75 years with Hip or Knee OA stage I to III
- Patient started current treatment with Theraflex not more than 2 weeks prior to inclusion into the study
- Personally signed and dated informed consent
Key exclusion criteria (8 listed)
- Patients participating in an investigational program with interventions outside of routine clinical practice
- Patients with Hip or Knee OA stage 0 or stage IV
- Patients who have both Hip and Knee OA and OA of any other location
- Contraindications for use of Theraflex in accordance with approved label(known hypersensitivity, severe chronic renal failure)
- Females who are pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theraflex, BAY 874017The 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 | Drug | Participants with Stage I-III Hip osteoarthritis (HOA), Participants with Stage I-III Knee osteoarthritis (KOA) |
Primary outcome
Changes in the Pain Intensity Subscale
Time frame: From enrollment up to 64 weeks
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.
Changes in Other Symptoms Subscale
Time frame: From enrollment up to 64 weeks
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.
Change in Functional Activity of the Joint Subscale
Time frame: From enrollment up to 64 weeks
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.
Change in Life Quality Subscale
Time frame: From enrollment up to 64 weeks
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.
4 secondary outcomes
Number of Participant Compliance With Drug Utilization of Theraflex
Time frame: From enrollment up to 64 weeks
Change in Patient Satisfaction Assessment
Time frame: From enrollment up to 64 weeks
Number of Participant With Concomitant Therapy of the Target Joint Osteoarthritis (OA)
Time frame: 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
Time frame: From enrollment up to 64 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Bayer at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Pain Intensity Subscale (time frame: From enrollment up to 64 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.