OsteoarthritisPhase 4RESPOND-EUROPENCT01429168
A Study of Etoricoxib in Participants With Osteoarthritis Not Responding to Analgesic Drugs (MK-0663-142)
A Phase 4 study testing Etoricoxib in people with Osteoarthritis, run by Organon and Co.
Trial summary
This two-part study will evaluate the effectiveness of etoricoxib in controlling pain in participants with osteoarthritis who are experiencing inadequate response to their current treatments. In Part 1, all participants will receive open-label etoricoxib 60 mg daily. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Etoricoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Aug 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of osteoarthritis of the knee or hip that requires treatment
- American Rheumatism Association (ARA) functional Class I, II or III
- Receiving a stable dose of a traditional non-steroidal anti-inflammatory drug (NSAID), a Cox-2 selective inhibitor (other than etoricoxib, e.g. celecoxib), opioid therapy or tramadol to treat their osteoarthritis-related pain for at least 2 weeks and willing to maintain treatment during baseline phase
- Moderate to severe daily pain intensity on his or her current pain regimen
- Excepting osteoarthritis, patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests
- Negative serum pregnancy test
Who cannot join
- Has not experienced at least 3 consecutive days of daily pain intensity >4 on 10-point scale
- Severe hepatic insufficiency
- Advanced renal insufficiency
- Presence of gastro-intestinal ulcer disease with active bleeding or history of the same within the past 6 months or a presence or history of inflammatory bowel disease
- History of gastric, biliary (including gastric bypass surgery), or small intestinal surgery that results in clinical malabsorption
- Receiving or will likely require treatment with ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids
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- Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease including a history of stroke, myocardial infarction or transient ischemic attack, and recent revascularization procedures
- Any other contraindications mentioned in the approved study drug European Union (EU) Summary of Product Characteristics (SmPC)
- Therapy with glucosamine and/or chondroitin sulfate for <6 months prior to study start.
About this study
Official title: The Randomized Etoricoxib Study in Patients With Osteoarthritis Not Responding to Analgesic Drugs - THE RESPOND-EUROPE STUDY
This two-part study will evaluate the effectiveness of etoricoxib in controlling pain in participants with osteoarthritis who are experiencing inadequate response to their current treatments. In Part 1, all participants will receive open-label etoricoxib 60 mg daily. Those participants who experience a clinically meaningful response to etoricoxib 60 mg daily within two weeks will be eligible to enter the double-blind withdrawal period (Part II). Responders entering Part 2 will be randomized in a 1:1 ratio to receive either etoricoxib 60 mg or placebo.
- Conditions
- Osteoarthritis
- Being tested
- Etoricoxib, Placebo for etoricoxib
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoricoxibDrug
Also called MK-0663
One 60-mg tablet orally daily
Placebo for etoricoxibDrug
One 60-mg tablet orally daily
| Study group | Role | What they receive |
|---|---|---|
| Part 1: All Enrolled Participants | Experimental | All participants will receive open-label etoricoxib 60 mg orally daily during Part 1. Receives: Drug: Etoricoxib |
| Part 2: Etoricoxib | Experimental | Not described Receives: Drug: Etoricoxib |
| Part 2: Placebo | Placebo comparator | Not described Receives: Drug: Placebo for etoricoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Time to Loss of Efficacy in the Double Blind Withdrawal Period (Part 2)
Measured: Week 3 to Week 7
Secondary outcomes (3)
Proportion of Participants who Achieve ≥30% Reduction in Pain During Part I
Measured: Week 1 to Week 3
Change in Mean of Daily Pain Scores
Measured: Week 1 to Week 7
Proportion of Participants Meeting Criteria for Loss of Efficacy in Part 2
Measured: Week 3 to Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429168
- Sponsor's protocol ID
- 0663-142
- Acronym
- RESPOND-EUROPE
- Status last verified
- Feb 2022
- First submitted
- 2 Sep 2011
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized Etoricoxib Study in Patients With Osteoarthritis Not Responding to Analgesic Drugs - THE RESPOND-EUROPE STUDY
- ClinicalTrials.gov ID
- NCT01429168
- Acronym / sponsor ID
- RESPOND-EUROPE / 0663-142
- Conditions
- Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 5 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This two-part study will evaluate the effectiveness of etoricoxib in controlling pain in participants with osteoarthritis who are experiencing inadequate response to their current treatments. In Part 1, all participants will receive open-label etoricoxib 60 mg daily. Those participants who experience a clinically meaningful response to etoricoxib 60 mg daily within two weeks will be eligible to enter the double-blind withdrawal period (Part II). Responders entering Part 2 will be randomized in a 1:1 ratio to receive either etoricoxib 60 mg or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: All Enrolled Participants | Experimental | Drug: EtoricoxibAll participants will receive open-label etoricoxib 60 mg orally daily during Part 1. |
| Part 2: Etoricoxib | Experimental | Drug: Etoricoxib |
| Part 2: Placebo | Placebo comparator | Drug: Placebo for etoricoxib |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of osteoarthritis of the knee or hip that requires treatment
- American Rheumatism Association (ARA) functional Class I, II or III
- Receiving a stable dose of a traditional non-steroidal anti-inflammatory drug (NSAID), a Cox-2 selective inhibitor (other than etoricoxib, e.g. celecoxib), opioid therapy or tramadol to treat their osteoarthritis-related pain for at least 2 weeks and willing to maintain treatment during baseline phase
- Moderate to severe daily pain intensity on his or her current pain regimen
- Excepting osteoarthritis, patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests
Key exclusion criteria (9 listed)
- Has not experienced at least 3 consecutive days of daily pain intensity >4 on 10-point scale
- Severe hepatic insufficiency
- Advanced renal insufficiency
- Presence of gastro-intestinal ulcer disease with active bleeding or history of the same within the past 6 months or a presence or history of inflammatory bowel disease
- History of gastric, biliary (including gastric bypass surgery), or small intestinal surgery that results in clinical malabsorption
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 |
|---|---|---|
| EtoricoxibAlso: MK-0663One 60-mg tablet orally daily | Drug | Part 1: All Enrolled Participants, Part 2: Etoricoxib |
| Placebo for etoricoxibOne 60-mg tablet orally daily | Drug | Part 2: Placebo |
Primary outcome
Mean Time to Loss of Efficacy in the Double Blind Withdrawal Period (Part 2)
Time frame: Week 3 to Week 7
3 secondary outcomes
Proportion of Participants who Achieve ≥30% Reduction in Pain During Part I
Time frame: Week 1 to Week 3
Change in Mean of Daily Pain Scores
Time frame: Week 1 to Week 7
Proportion of Participants Meeting Criteria for Loss of Efficacy in Part 2
Time frame: Week 3 to Week 7
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etoricoxib in people with 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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 18 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mean Time to Loss of Efficacy in the Double Blind Withdrawal Period (Part 2) (time frame: Week 3 to Week 7). 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 18 Feb 2022.