Spondylitis, AnkylosingPhase 3NCT01208207

A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108)

A Phase 3 study testing Part I - etoricoxib 60 mg, Part I - etoricoxib 90 mg and Part I- naproxen 1000 mg in people with Spondylitis, Ankylosing, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Spondylitis, Ankylosing
What is being tested?: Part I - etoricoxib 60 mg, Part I - etoricoxib 90 mg and Part I- naproxen 1000 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,015 participants
Where: No sites listed yet
Study dates: 27 Sep 2010to 12 Nov 2014
Phase: Phase 3
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has a definite diagnosis of Ankylosing Spondylitis (AS) per Modified New York Criteria made at least 6 months prior to screening
Has a history of positive therapeutic benefit with non-steroidal anti-inflammatory drugs (NSAIDs) and regular use of NSAIDS for past 30 days
Has a score on Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 at screening visit that is <77 mm
Must demonstrate sufficient "flare" or worsening of AS pain
Is in general good health (other than AS)
Has had approved non-study antirheumatic therapy that has been at stable dosing AND is not anticipated to undergo a change within the first 6 weeks of the protocol

Who cannot join

Has inflammatory arthritis (eg, rheumatoid arthritis, psoriatic arthritis, crystal-induced arthritis, spondyloarthropathy, diffuse idiopathic skeletal hyperostosis [DISH]), polymyalgia rheumatica, a history of septic arthritis or intra-articular fracture of the study joint, Wilson's disease, hemachromatosis, ochronosis, or primary osteochondromatosis
Has acute peripheral articular disease (onset within 4 weeks prior to screening) of an active (painful or swollen) peripheral arthritis
Has a history of gastric or biliary surgery, or small intestine surgery that causes clinical malabsorption
Has had an active peptic (gastric or duodenal) ulcer or history of inflammatory bowel disease
Has undergone coronary artery bypass graft surgery (CABG), angioplasty, or has a cerebrovascular accident or transient ischemic attack within the past 6 months or has active ischemic heart disease, cerebrovascular disease, or peripheral vascular disease
Has Class II-IV congestive heart failure

Show all 14Show fewer

Has uncontrolled hypertension
Has a history of neoplastic disease, except adequately treated basal cell carcinoma or carcinoma in situ of the cervix, or malignancies that have been successfully treated ≥ 5 years prior to screening
Has history of leukemia, lymphoma, malignant melanoma, and myeloproliferative disease
Allergy to etoricoxib or naproxen, or history of a significant clinical or laboratory adverse experience associated with etoricoxib or naproxen
Has a history or family history of an inherited or acquired bleeding disorder
Is considered morbidly obese and demonstrates significant health problems stemming from obesity, which would confound study participation or interpretation of study results
Is pregnant, breast-feeding, or expecting to conceive during the study
Has a clinical diagnosis of hepatic insufficiency defined as Child-Pugh score ≥ 5

About this study

Official title: A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Ankylosing Spondylitis

The purpose of the study is to evaluate the efficacy and tolerability of two doses of etoricoxib compared to naproxen in the treatment of ankylosing spondylitis (AS). The primary objectives are to evaluate the improvement in Spinal Pain Intensity over 6 weeks of treatment with etoricoxib 90 mg or 60 mg compared to naproxen; and to evaluate the improvement in Spinal Pain Intensity over 6 weeks of treatment with etoricoxib 90 mg compared with etoricoxib 60 mg. Additionally the added benefit of increasing the dose of etoricoxib from 60 mg to 90 mg will be assessed in the second part of the study. The primary hypothesis is that the improvement in Spinal Pain Intensity visual analog scale (VAS) as measured by the time-weighted average (TWA) change from baseline over 6 weeks of treatment in Part I for etoricoxib 90 mg or 60 mg once daily is not inferior to naproxen 1000 mg.

Conditions: Spondylitis, Ankylosing
Being tested: Part I - etoricoxib 60 mg, Part I - etoricoxib 90 mg, Part I- naproxen 1000 mg, Part I - Placebo to naproxen 500 mg, Part II- etoricoxib 60 mg
Medical subject headings: Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Part I - etoricoxib 60 mgDrug
Also called MK-0663
etoricoxib 60 mg oral tablet once daily for 6 weeks
Part I - etoricoxib 90 mgDrug
Also called Mk-0663
etoricoxib 90 mg oral tablet once daily for 6 weeks
Part I- naproxen 1000 mgDrug
naproxen 500 mg oral tablet twice daily for 6 weeks
Part I - Placebo to naproxen 500 mgDrug
Placebo to naproxen 500 mg oral tablet twice daily for 6 weeks
Part II- etoricoxib 60 mgDrug
Also called MK-0663
etoricoxib 60 mg oral tablet once daily for 20 weeks
Part II- etoricoxib 90 mgDrug
Also called MK-0663
etoricoxib 90 mg oral tablet once daily for 20 weeks
Part II- naproxen 1000 mgDrug
naproxen 500 mg oral tablet twice daily for 20 weeks
Part I - Placebo to etoricoxib 60 mgDrug
Placebo to etoricoxib 60 mg oral tablet once daily for 6 weeks.
Part I - Placebo to etoricoxib 90 mgDrug
Placebo to etoricoxib 90 mg oral tablet once daily for 6 weeks.
Part II- Placebo to etoricoxib 60 mgDrug
Placebo to etoricoxib 60 mg oral tablet once daily for 20 weeks.
Part II - Placebo to etoricoxib 90 mgDrug
Placebo to etoricoxib 90 mg oral tablet once daily for 20 weeks.
Part II- Placebo to naproxen 500 mgDrug
Placebo to naproxen 500 mg orally twice daily for 20 weeks.

Study groups in NCT01208207
Study group	Role	What they receive
etoricoxib 60 mg/etoricoxib 60 mg	Experimental	The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg in Part I and Part II Receives: Drug: Part I - etoricoxib 60 mg; Drug: Part I - Placebo to naproxen 500 mg; Drug: Part II- etoricoxib 60 mg; Drug: Part I - Placebo to etoricoxib 90 mg; Drug: Part II - Placebo to etoricoxib 90 mg; Drug: Part II- Placebo to naproxen 500 mg
etoricoxib 60 mg/etoricoxib 90 mg	Experimental	The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg in Part I and etoricoxib 90 mg in Part II Receives: Drug: Part I - etoricoxib 60 mg; Drug: Part I - Placebo to naproxen 500 mg; Drug: Part II- etoricoxib 90 mg; Drug: Part I - Placebo to etoricoxib 90 mg; Drug: Part II- Placebo to etoricoxib 60 mg; Drug: Part II- Placebo to naproxen 500 mg
etoricoxib 90 mg/etoricoxib 90 mg	Experimental	The etoricoxib 90 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 90 mg in Part I and Part II Receives: Drug: Part I - etoricoxib 90 mg; Drug: Part I - Placebo to naproxen 500 mg; Drug: Part II- etoricoxib 90 mg; Drug: Part I - Placebo to etoricoxib 60 mg; Drug: Part II- Placebo to etoricoxib 60 mg; Drug: Part II- Placebo to naproxen 500 mg
naproxen 1000 mg/naproxen 1000 mg	Active comparator	The naproxen 1000 mg/naproxen 1000 mg treatment sequence will receive naproxen 1000 mg in Part I and Part II Receives: Drug: Part I- naproxen 1000 mg; Drug: Part II- naproxen 1000 mg; Drug: Part I - Placebo to etoricoxib 60 mg; Drug: Part I - Placebo to etoricoxib 90 mg; Drug: Part II- Placebo to etoricoxib 60 mg; Drug: Part II - Placebo to etoricoxib 90 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Naproxen
Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Measured: Baseline and up to Week 6
Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 60 mg vs. Naproxen
Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Measured: Baseline and up to Week 6
Number of Participants Discontinuing Study Treatment Due to an Adverse Event
Measured: Up to 26 weeks

Secondary outcomes (2)

Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Etoricoxib 60 mg
Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Measured: Baseline and up to Week 6
Average Change From Week 6 in the Spinal Pain Intensity Over Weeks 10 and 12 in Study Part 2: Etoricoxib 60/90 mg vs. Etoricoxib 60mg (Non-responders From Part I)
Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. Average change from Week 6 in Spinal Pain Intensity (VAS) over Weeks 10 and 12 is calculated as the average Spinal pain Intensity (VAS) value over Weeks 10 and 12 minus the Spinal Pain Intensity (VAS) at Week 6.
Measured: Week 6 to Week 10 and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 201012 Nov 2014

First posted23 Sep 2010 (estimated)
Study start27 Sep 2010
Primary completion12 Nov 2014
Study completion12 Nov 2014

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Spondylitis, AnkylosingStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,015 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01208207
Sponsor's protocol ID: 0663-108
Status last verified: Feb 2022
First submitted: 22 Sep 2010
Last updated: 18 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Balazcs E, Sieper J, Bickham K, Mehta A, Frontera N, Stryszak P, Popmihajlov Z, Peloso PM. A randomized, clinical trial to assess the relative efficacy and tolerability of two doses of etoricoxib versus naproxen in patients with ankylosing spondylitis. BMC Musculoskelet Disord. 2016 Oct 13;17(1):426. doi: 10.1186/s12891-016-1275-5.
PubMed 27737664

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
Not yet recruitingPhase 1
A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis

All Spondylitis, Ankylosing trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Ankylosing Spondylitis
ClinicalTrials.gov ID: NCT01208207
Acronym / sponsor ID: 0663-108
Conditions: Spondylitis, Ankylosing
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,015 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 27 Sep 2010 (actual)
Primary completion: 12 Nov 2014 (actual)
Study completion: 12 Nov 2014 (actual)
First posted: 23 Sep 2010 (estimated)
Results: Posted 2 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
etoricoxib 60 mg/etoricoxib 60 mg	Experimental	Drug: Part I - etoricoxib 60 mg, Drug: Part I - Placebo to naproxen 500 mg, Drug: Part II- etoricoxib 60 mg, Drug: Part I - Placebo to etoricoxib 90 mg, Drug: Part II - Placebo to etoricoxib 90 mg, Drug: Part II- Placebo to naproxen 500 mgThe etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg in Part I and Part II
etoricoxib 60 mg/etoricoxib 90 mg	Experimental	Drug: Part I - etoricoxib 60 mg, Drug: Part I - Placebo to naproxen 500 mg, Drug: Part II- etoricoxib 90 mg, Drug: Part I - Placebo to etoricoxib 90 mg, Drug: Part II- Placebo to etoricoxib 60 mg, Drug: Part II- Placebo to naproxen 500 mgThe etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg in Part I and etoricoxib 90 mg in Part II
etoricoxib 90 mg/etoricoxib 90 mg	Experimental	Drug: Part I - etoricoxib 90 mg, Drug: Part I - Placebo to naproxen 500 mg, Drug: Part II- etoricoxib 90 mg, Drug: Part I - Placebo to etoricoxib 60 mg, Drug: Part II- Placebo to etoricoxib 60 mg, Drug: Part II- Placebo to naproxen 500 mgThe etoricoxib 90 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 90 mg in Part I and Part II
naproxen 1000 mg/naproxen 1000 mg	Active comparator	Drug: Part I- naproxen 1000 mg, Drug: Part II- naproxen 1000 mg, Drug: Part I - Placebo to etoricoxib 60 mg, Drug: Part I - Placebo to etoricoxib 90 mg, Drug: Part II- Placebo to etoricoxib 60 mg, Drug: Part II - Placebo to etoricoxib 90 mgThe naproxen 1000 mg/naproxen 1000 mg treatment sequence will receive naproxen 1000 mg in Part I and Part II

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Has a definite diagnosis of Ankylosing Spondylitis (AS) per Modified New York Criteria made at least 6 months prior to screening
Has a history of positive therapeutic benefit with non-steroidal anti-inflammatory drugs (NSAIDs) and regular use of NSAIDS for past 30 days
Has a score on Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Question 2 at screening visit that is <77 mm
Must demonstrate sufficient "flare" or worsening of AS pain
Is in general good health (other than AS)

Key exclusion criteria (14 listed)

Has inflammatory arthritis (eg, rheumatoid arthritis, psoriatic arthritis, crystal-induced arthritis, spondyloarthropathy, diffuse idiopathic skeletal hyperostosis [DISH]), polymyalgia rheumatica, a history of septic arthritis or intra-articular fracture of the study joint, Wilson's disease, hemachromatosis, ochronosis, or primary osteochondromatosis
Has acute peripheral articular disease (onset within 4 weeks prior to screening) of an active (painful or swollen) peripheral arthritis
Has a history of gastric or biliary surgery, or small intestine surgery that causes clinical malabsorption
Has had an active peptic (gastric or duodenal) ulcer or history of inflammatory bowel disease
Has undergone coronary artery bypass graft surgery (CABG), angioplasty, or has a cerebrovascular accident or transient ischemic attack within the past 6 months or has active ischemic heart disease, cerebrovascular disease, or peripheral vascular disease

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
Part I - etoricoxib 60 mgAlso: MK-0663etoricoxib 60 mg oral tablet once daily for 6 weeks	Drug	etoricoxib 60 mg/etoricoxib 60 mg, etoricoxib 60 mg/etoricoxib 90 mg
Part I - etoricoxib 90 mgAlso: Mk-0663etoricoxib 90 mg oral tablet once daily for 6 weeks	Drug	etoricoxib 90 mg/etoricoxib 90 mg
Part I- naproxen 1000 mgnaproxen 500 mg oral tablet twice daily for 6 weeks	Drug	naproxen 1000 mg/naproxen 1000 mg
Part I - Placebo to naproxen 500 mgPlacebo to naproxen 500 mg oral tablet twice daily for 6 weeks	Drug	etoricoxib 60 mg/etoricoxib 60 mg, etoricoxib 60 mg/etoricoxib 90 mg, etoricoxib 90 mg/etoricoxib 90 mg
Part II- etoricoxib 60 mgAlso: MK-0663etoricoxib 60 mg oral tablet once daily for 20 weeks	Drug	etoricoxib 60 mg/etoricoxib 60 mg
Part II- etoricoxib 90 mgAlso: MK-0663etoricoxib 90 mg oral tablet once daily for 20 weeks	Drug	etoricoxib 60 mg/etoricoxib 90 mg, etoricoxib 90 mg/etoricoxib 90 mg
Part II- naproxen 1000 mgnaproxen 500 mg oral tablet twice daily for 20 weeks	Drug	naproxen 1000 mg/naproxen 1000 mg
Part I - Placebo to etoricoxib 60 mgPlacebo to etoricoxib 60 mg oral tablet once daily for 6 weeks.	Drug	etoricoxib 90 mg/etoricoxib 90 mg, naproxen 1000 mg/naproxen 1000 mg
Part I - Placebo to etoricoxib 90 mgPlacebo to etoricoxib 90 mg oral tablet once daily for 6 weeks.	Drug	etoricoxib 60 mg/etoricoxib 60 mg, etoricoxib 60 mg/etoricoxib 90 mg, naproxen 1000 mg/naproxen 1000 mg
Part II- Placebo to etoricoxib 60 mgPlacebo to etoricoxib 60 mg oral tablet once daily for 20 weeks.	Drug	etoricoxib 60 mg/etoricoxib 90 mg, etoricoxib 90 mg/etoricoxib 90 mg, naproxen 1000 mg/naproxen 1000 mg
Part II - Placebo to etoricoxib 90 mgPlacebo to etoricoxib 90 mg oral tablet once daily for 20 weeks.	Drug	etoricoxib 60 mg/etoricoxib 60 mg, naproxen 1000 mg/naproxen 1000 mg
Part II- Placebo to naproxen 500 mgPlacebo to naproxen 500 mg orally twice daily for 20 weeks.	Drug	etoricoxib 60 mg/etoricoxib 60 mg, etoricoxib 60 mg/etoricoxib 90 mg, etoricoxib 90 mg/etoricoxib 90 mg

Primary outcome

Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Naproxen
Time frame: Baseline and up to Week 6
Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 60 mg vs. Naproxen
Time frame: Baseline and up to Week 6
Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.
Number of Participants Discontinuing Study Treatment Due to an Adverse Event
Time frame: Up to 26 weeks

2 secondary outcomes

Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Etoricoxib 60 mg
Time frame: Baseline and up to Week 6
Average Change From Week 6 in the Spinal Pain Intensity Over Weeks 10 and 12 in Study Part 2: Etoricoxib 60/90 mg vs. Etoricoxib 60mg (Non-responders From Part I)
Time frame: Week 6 to Week 10 and Week 12

Results and safety

Results posted to the registry on 2 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etoricoxib 60 mg (Part I)	702	632
Etoricoxib 90 mg (Part I)	156	145
Naproxen 1000 mg (Part I)	157	142
Etoricoxib 60 mg / 60 mg (Part II)	0	0
Etoricoxib 60 mg / 90 mg (Part II)	0	0
Etoricoxib 90 mg / 90 mg (Part II)	0	0
Naproxen 1000 mg (Part II)	0	0

Primary outcome: Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Naproxen

Time frame: Baseline and up to Week 6. Least squares mean (95% Confidence Interval). Unit: mm VAS

Measure	Etoricoxib 90 mg n = 144	Naproxen 1000 mg n = 143
Value	-31.23 (-34.70 to -27.76)	-30.59 (-34.07 to -27.10)

Etoricoxib 90 mg vs Naproxen 1000 mg: Difference in Least Squares Mean: -0.64 (95% CI -5.47 to 4.19), ANCOVA

Population analysed: Per-Protocol Population - excluded participants due to important protocol deviations that may have had a substantial effect on the result of the primary efficacy endpoint.

Primary outcome: Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 60 mg vs. Naproxen

Time frame: Baseline and up to Week 6. Least squares mean (95% Confidence Interval). Unit: mm VAS

Measure	Etoricoxib 60 mg n = 660	Naproxen 1000 mg n = 143
Value	-29.00 (-30.69 to -27.31)	-30.59 (-34.07 to -27.10)

Etoricoxib 60 mg vs Naproxen 1000 mg: Difference in Least Squares Mean: 1.59 (95% CI -2.19 to 5.37), ANCOVA

Population analysed: Per-Protocol Population - excluded participants due to important protocol deviations that may have had a substantial effect on the result of the primary efficacy endpoint.

Primary outcome: Number of Participants Discontinuing Study Treatment Due to an Adverse Event

Time frame: Up to 26 weeks. Number. Unit: Participants

Measure	Etoricoxib 60 mg (Part I) n = 702	Etoricoxib 90 mg (Part I) n = 155	Naproxen 1000 mg (Part I) n = 156	Etoricoxib 60 mg / 60 mg (Part II) n = 313	Etoricoxib 60 mg / 90 mg (Part II) n = 319	Etoricoxib 90 mg / 90 mg (Part II) n = 145	Naproxen 1000 mg (Part II) n = 142
Value	22	2	6	3	9	4	2

Population analysed: All Patients as Treated Population (APaT) - Participants were included in the treatment group corresponding to the study treatment they actually received. One participant randomized to 60 mg in Part II received 90 mg in Part II, and; therefore, was included in the Etoricoxib 60mg / 90mg (Part II) arm.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 30 (including up to 28 days after last dose of study drug). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etoricoxib 60 mg / Etoricoxib 60 mg	1 of 313 (0.3%)	55 of 313 (17.6%)	Not reported
Etoricoxib 60 mg / Etoricoxib 90 mg	7 of 319 (2.2%)	50 of 319 (15.7%)	Not reported
Etoricoxib 90 mg / Etoricoxib 90 mg	6 of 145 (4.1%)	24 of 145 (16.6%)	Not reported
Naproxen 1000 mg / Naproxen 1000 mg	2 of 142 (1.4%)	25 of 142 (17.6%)	Not reported
Etoricoxib 60 mg	5 of 70 (7.1%)	18 of 70 (25.7%)	Not reported
Etoricoxib 90 mg	0 of 10 (0%)	6 of 10 (60%)	Not reported
Naproxen 1000 mg	0 of 14 (0%)	9 of 14 (64.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27737664Balazcs E, Sieper J, Bickham K, Mehta A, Frontera N, Stryszak P, Popmihajlov Z, Peloso PM. A randomized, clinical trial to assess the relative efficacy and tolerability of two doses of etoricoxib versus naproxen in patients with ankylosing spondylitis. BMC Musculoskelet Disord. 2016 Oct 13;17(1):426. doi: 10.1186/s12891-016-1275-5.
Individual participant dataSharing planned: No

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Part I - etoricoxib 60 mg, Part I - etoricoxib 90 mg and Part I- naproxen 1000 mg in people with Spondylitis, Ankylosing, 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 14 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 18 Jun 2024. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2015). 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?

Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Naproxen (time frame: Baseline and up to Week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01208207, which also lists 1 linked publication.

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 Jun 2024.