OsteoarthritisCOXIBUSNCT01572675
A Study of the Patterns of Use of Etoricoxib in France (MK-0663-148)
An observational study of Osteoarthritis, run by Organon and Co.
Trial summary
This postmarketing study will examine the use of etoricoxib (Arcoxia®) in routine clinical practice in France as well as the use of celecoxib (Celebrex®). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- etorocoxib and celecoxib
- Type of treatment
- Pill or oral medicine
- How many people
- 547 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Mar 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants spontaneously consulting a general practitioner or rheumatologist and having agreed to take part in this study.
Who may be able to join
- Treatment-naive, discontinued the previous treatment course of etoricoxib or celecoxib at least 3 months previously or currently receiving continuous treatment with oral etoricoxib or celecoxib
- Consent to take part in the study
- Included in his/her physician's client base for at least 1 year
Who cannot join
- Unable to receive follow-up over a year
- Included in an interventional trial
About this study
Official title: Pharmacoepidemiological Study on the Use of Arcoxia® Under Actual Conditions of Use in France
This postmarketing study will examine the use of etoricoxib (Arcoxia®) in routine clinical practice in France as well as the use of celecoxib (Celebrex®).
- Conditions
- Osteoarthritis
- Being tested
- etorocoxib, celecoxib
- Keywords
- Pharmacoepidemiological, Longitudinal, Observational
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etorocoxibDrug
Also called Arcoxia®
Administered as 30 mg or 60 mg oral film-coated tablets
celecoxibDrug
Also called Celebrex®
Administered as 100 mg or 200 mg oral hard capsules
| Study group | Role | What they receive |
|---|---|---|
| Group Arcoxia® | Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Receives: Drug: etorocoxib | |
| Group Celebrex® | Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. Receives: Drug: celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Demonstrating Proper Use of Arcoxia® and Celebrex®
Proper use of study medication is defined as administration of medication in terms of indication and dosage according to Market Authorization (MA). Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.
Measured: Up to 12 months
Reasons for Misuse of Arcoxia® and Celebrex®
Proper use of study medication is defined as administration of medication in terms of indication and dosage according to MA. Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.
Measured: Up to 12 months
Indications for Which Arcoxia® and Celebrex® Were Prescribed
The reasons (indications) for prescribing of Arcoxia® or Celebrex® were collected in open-field forms by the Investigator; category assignment (i.e, re-codification) of verbatim entries was conducted by a group of medical experts under the guidance approved by the MA. This endpoint gives the number of participants treated per indication.
Measured: At study entry
Dosage of Arcoxia® and Celebrex® at Initiation
Dosage at initiation of treatment with Arcoxia® or Celebrex® was identified. MA compliant dosage at initiation corresponds to a (starting) dose of 30 mg daily for Arcoxia® or a (starting) dose of 200 mg daily for Celebrex®. The dose for initiation was calculated by multiplying the number of doses per day with the dose level (total daily dose) as noted in the prescription record.
Measured: At study entry
Mean Dosage of Arcoxia® and Celebrex® During Treatment
The mean dosage of Arcoxia® and Celebrex® during treatment was determined. For participants who stopped treatment after their initial study visit, the maximum dose recorded at their final study visit was considered when calculating their mean dosage during treatment.
Measured: Up to 12 months
Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex®
Participants requiring modifications to their Arcoxia® or Celebrex® dose regimens during their on study treatment course were identified. Dose modifications were defined as an increase, decrease followed by increase, decrease, or increase followed by decrease in the participant's daily dose; all categorizations were exclusive. If the maximum dose at discontinuation of treatment was greater than that at initiation, the participant was considered as having had an increase in dose during treatment. Alternatively, if data obtained from a participant's prescription records showed a successive lowering of dosage, the participant was considered as having had a decrease in dose during treatment. Dosages at baseline were included in the dose modification determination for treatment renewal participants.
Measured: Up to 12 months
Duration of Prescription for Arcoxia® and Celebrex® at Enrollment
The mean duration of prescription at enrollment for participants treated with Arcoxia® and Celebrex® was determined using the participant's record.
Measured: Up to 3 months prior to study entry
Total Duration of Treatment With Arcoxia® and Celebrex®
The total duration of treatment (DoT) with Arcoxia® or Celebrex® was determined for populations that achieved end-of study and end-of-protocol or that were categorized as lost to follow-up. Participants enumerated as end-of-study had their treatment discontinued during the protocol-specified one year of follow-up. Participants enumerated as end-of-protocol were ongoing treatment at end of the protocol-specified one year of follow-up. Participants categorized as lost to follow-up had no follow-up visit where a determination of discontinuation from treatment could be made.
Measured: Up to 12 months
Maximum Dosage Prescribed During Treatment With Arcoxia® and Celebrex®
Mean maximum dosage prescribed during follow-up in participants treated with Arcoxia® or Celebrex®. Dosage is expressed as total daily dose.
Measured: Up to 12 months
Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®
The individual reasons for discontinuation of treatment with Arcoxia® or Celebrex® were identified over the course of study through either physician selection from a pre-determined list or verbatim entry by the physician with subsequent re-codification by Sponsor.
Measured: Up to 12 months
Type of Arcoxia® and Celebrex® Use
The type of Arcoxia® or Celebrex® use during the study was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days) by the Investigating Physician at time of treatment discontinuation.
Measured: Up to 12 months
Type of Arcoxia® and Celebrex® Use According to Duration of Treatment
Use of selective cyclooxygenase-2 (COX-2) inhibitors (Arcoxia® and Celebrex®) as assessed by the Investigating Physician at time of treatment discontinuation was correlated to the overall duration of treatment experienced by the participant (i.e., intermittent or continuous selective COX-2 inhibitor use vs. total participant time on treatment). Type of use was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days). Four successive treatment intervals were assessed in this endpoint: 1) Up to thirty days of treatment 2) From one to three months of treatment 3) From three months to one year of treatment and 4) More than one year of treatment.
Measured: Up to 12 months
Secondary outcomes (13)
Mean Body Mass Index (BMI) at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Participants' BMI was assessed at study entry by the Investigating Physician. BMI is calculated as the participant's weight in kilograms (kg) divided by height in meters squared. BMI under 18.5 is commonly considered underweight; within the range (18.5 to 25) as normal weight; within the range (25 to 30) as overweight; and over 30 as obese.
Measured: At study entry (baseline)
Mean Systolic and Diastolic Blood Pressure (BP) at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) were assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.
Measured: At study entry (baseline)
Blood Pressure at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Participants' BP (SBP/DBP) was assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.
Measured: At study entry (baseline)
Medical History of Participants Treated With Arcoxia® and Celebrex®
Relevant medical history of participants treated with Arcoxia® or Celebrex® was recorded by the Investigating Physician.
Measured: At study entry
Co-morbidities in Participants Treated With Arcoxia® and Celebrex®
Associated co-morbidities at study entry (baseline) in participants treated with Arcoxia® or Celebrex® were recorded by the Investigating Physician. CHF/IHD/PAD = Congestive heart failure/Ischemic heart disease/Peripheral artery disease
Measured: At study entry
Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®
'Significant' treatments that preceded the use of selective COX-2 inhibitors (Arcoxia® or Celebrex®) were identified using a closed-ended (yes/ no/ do not know) questionnaire. Significant is defined as associated with a chronic disease or having a potential link with participant's current use of a selective COX-2 inhibitors (Arcoxia® or Celebrex®). ARBs = Angiotensin 2 receptor blockers. ACEIs = Angiotensin-converting enzyme inhibitors. SSRIs = Selective serotonin reuptake Inhibitors. PAIs = Platelet aggregation inhibitors.
Measured: At study entry
Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Concomitant medications prescribed to participants treated with Arcoxia® and Celebrex® were collected via the physician prescription note at time of participant's study entry. NSAIDS = Non-steroidal anti-inflammatory agents.
Measured: At study entry
Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
Concomitant medications prescribed during the course of follow-up to participants treated with Arcoxia® and Celebrex® were extracted from participants' medical records. NSAIDS = Non-steroidal anti-inflammatory agents.
Measured: Up to 12 months
Number of Participants Treated With Other Agents Prior to Initiation of Arcoxia® and Celebrex®
Other prescribed agents for the same study indication within 3 months preceding the decision to initiate treatment with selective COX-2 inhibitors (Arcoxia® or Celebrex®) were determined using the participant's medical record. NSAIDS = Non-steroidal inflammatory agents.
Measured: Up to 3 months prior to study entry
Number of Participants Switching to Another Treatment With the Same Reason for Prescription
Participants who switched to another NSAID or other therapy for the same reason for prescription upon discontinuation of treatment with Arcoxia® or Celebrex® were determined.
Measured: Up to 12 months
Number of Participants With Contraindications for Use of Arcoxia®
Participants noted with contraindications for use of Arcoxia® according to the MA during initiation of treatment are described. CHF = congestive heart failure. HA = hepatic impairment. IBD = inflammatory bowel disease. IHD = ischemic heart disease. PAD = peripheral artery disease.
Measured: At study entry
Number of Participants Who Experienced at Least One Adverse Event
An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Measured: Up to 12 months
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2015
- Study completionMar 2015
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.
- 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
- 547 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572675
- Sponsor's protocol ID
- 0663-148
- Acronym
- COXIBUS
- Status last verified
- Feb 2022
- First submitted
- 3 Feb 2012
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacoepidemiological Study on the Use of Arcoxia® Under Actual Conditions of Use in France
- ClinicalTrials.gov ID
- NCT01572675
- Acronym / sponsor ID
- COXIBUS / 0663-148
- Conditions
- Osteoarthritis
- Keywords
- Pharmacoepidemiological, Longitudinal, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 547 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Apr 2012 (estimated)
- Results
- Posted 25 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This postmarketing study will examine the use of etoricoxib (Arcoxia®) in routine clinical practice in France as well as the use of celecoxib (Celebrex®).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Arcoxia® | – | Drug: etorocoxibParticipants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
| Group Celebrex® | – | Drug: celecoxibParticipants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants spontaneously consulting a general practitioner or rheumatologist and having agreed to take part in this study.
Key inclusion criteria (3 listed)
- Treatment-naive, discontinued the previous treatment course of etoricoxib or celecoxib at least 3 months previously or currently receiving continuous treatment with oral etoricoxib or celecoxib
- Consent to take part in the study
- Included in his/her physician's client base for at least 1 year
Key exclusion criteria (2 listed)
- Unable to receive follow-up over a year
- Included in an interventional trial
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 |
|---|---|---|
| etorocoxibAlso: Arcoxia®Administered as 30 mg or 60 mg oral film-coated tablets | Drug | Group Arcoxia® |
| celecoxibAlso: Celebrex®Administered as 100 mg or 200 mg oral hard capsules | Drug | Group Celebrex® |
Primary outcome
Number of Participants Demonstrating Proper Use of Arcoxia® and Celebrex®
Time frame: Up to 12 months
Proper use of study medication is defined as administration of medication in terms of indication and dosage according to Market Authorization (MA). Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.
Reasons for Misuse of Arcoxia® and Celebrex®
Time frame: Up to 12 months
Proper use of study medication is defined as administration of medication in terms of indication and dosage according to MA. Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.
Indications for Which Arcoxia® and Celebrex® Were Prescribed
Time frame: At study entry
The reasons (indications) for prescribing of Arcoxia® or Celebrex® were collected in open-field forms by the Investigator; category assignment (i.e, re-codification) of verbatim entries was conducted by a group of medical experts under the guidance approved by the MA. This endpoint gives the number of participants treated per indication.
Dosage of Arcoxia® and Celebrex® at Initiation
Time frame: At study entry
Dosage at initiation of treatment with Arcoxia® or Celebrex® was identified. MA compliant dosage at initiation corresponds to a (starting) dose of 30 mg daily for Arcoxia® or a (starting) dose of 200 mg daily for Celebrex®. The dose for initiation was calculated by multiplying the number of doses per day with the dose level (total daily dose) as noted in the prescription record.
Mean Dosage of Arcoxia® and Celebrex® During Treatment
Time frame: Up to 12 months
The mean dosage of Arcoxia® and Celebrex® during treatment was determined. For participants who stopped treatment after their initial study visit, the maximum dose recorded at their final study visit was considered when calculating their mean dosage during treatment.
Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex®
Time frame: Up to 12 months
Participants requiring modifications to their Arcoxia® or Celebrex® dose regimens during their on study treatment course were identified. Dose modifications were defined as an increase, decrease followed by increase, decrease, or increase followed by decrease in the participant's daily dose; all categorizations were exclusive. If the maximum dose at discontinuation of treatment was greater than that at initiation, the participant was considered as having had an increase in dose during treatment. Alternatively, if data obtained from a participant's prescription records showed a successive lowering of dosage, the participant was considered as having had a decrease in dose during treatment. Dosages at baseline were included in the dose modification determination for treatment renewal participants.
Duration of Prescription for Arcoxia® and Celebrex® at Enrollment
Time frame: Up to 3 months prior to study entry
The mean duration of prescription at enrollment for participants treated with Arcoxia® and Celebrex® was determined using the participant's record.
Total Duration of Treatment With Arcoxia® and Celebrex®
Time frame: Up to 12 months
The total duration of treatment (DoT) with Arcoxia® or Celebrex® was determined for populations that achieved end-of study and end-of-protocol or that were categorized as lost to follow-up. Participants enumerated as end-of-study had their treatment discontinued during the protocol-specified one year of follow-up. Participants enumerated as end-of-protocol were ongoing treatment at end of the protocol-specified one year of follow-up. Participants categorized as lost to follow-up had no follow-up visit where a determination of discontinuation from treatment could be made.
Maximum Dosage Prescribed During Treatment With Arcoxia® and Celebrex®
Time frame: Up to 12 months
Mean maximum dosage prescribed during follow-up in participants treated with Arcoxia® or Celebrex®. Dosage is expressed as total daily dose.
Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®
Time frame: Up to 12 months
The individual reasons for discontinuation of treatment with Arcoxia® or Celebrex® were identified over the course of study through either physician selection from a pre-determined list or verbatim entry by the physician with subsequent re-codification by Sponsor.
Type of Arcoxia® and Celebrex® Use
Time frame: Up to 12 months
The type of Arcoxia® or Celebrex® use during the study was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days) by the Investigating Physician at time of treatment discontinuation.
Type of Arcoxia® and Celebrex® Use According to Duration of Treatment
Time frame: Up to 12 months
Use of selective cyclooxygenase-2 (COX-2) inhibitors (Arcoxia® and Celebrex®) as assessed by the Investigating Physician at time of treatment discontinuation was correlated to the overall duration of treatment experienced by the participant (i.e., intermittent or continuous selective COX-2 inhibitor use vs. total participant time on treatment). Type of use was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days). Four successive treatment intervals were assessed in this endpoint: 1) Up to thirty days of treatment 2) From one to three months of treatment 3) From three months to one year of treatment and 4) More than one year of treatment.
13 secondary outcomes
Mean Body Mass Index (BMI) at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Time frame: At study entry (baseline)
Mean Systolic and Diastolic Blood Pressure (BP) at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Time frame: At study entry (baseline)
Blood Pressure at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Time frame: At study entry (baseline)
Medical History of Participants Treated With Arcoxia® and Celebrex®
Time frame: At study entry
Co-morbidities in Participants Treated With Arcoxia® and Celebrex®
Time frame: At study entry
Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®
Time frame: At study entry
Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®
Time frame: At study entry
Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®
Time frame: Up to 12 months
Number of Participants Treated With Other Agents Prior to Initiation of Arcoxia® and Celebrex®
Time frame: Up to 3 months prior to study entry
Number of Participants Switching to Another Treatment With the Same Reason for Prescription
Time frame: Up to 12 months
Number of Participants With Contraindications for Use of Arcoxia®
Time frame: At study entry
Number of Participants Who Experienced at Least One Adverse Event
Time frame: Up to 12 months
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Time frame: Up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Organon and Co.
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 2 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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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 25 May 2016). 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?
Number of Participants Demonstrating Proper Use of Arcoxia® and Celebrex® (time frame: Up to 12 months). The study lists 12 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 9 Feb 2022.