Evidence map›Paper›PMID 27737664›Full record

Trial reportBMC musculoskeletal disorders2016

A randomized, clinical trial to assess the relative efficacy and tolerability of two doses of etoricoxib versus naproxen in patients with ankylosing spondylitis.

Eva Balazcs, Joachim Sieper, Kara Bickham, Anish Mehta, Nancy Frontera, Paul Stryszak, Zoran Popmihajlov, Paul M Peloso

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC musculoskeletal disorders, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01208207 (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), which is not on this map. Cited by 13 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 4 pooled it
3.0field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01208207 phase3completednot on this map

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

TypeinterventionalSponsorOrganon and CoRan2010 to 2014Enrolled1,015ConditionsSpondylitis, AnkylosingArmsPart 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
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 4 syntheses or guidelines pooled it, 28 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 2 countries.

Eva BalazcsDepartment of Neuromusculoskeletal Rehabilitation, Dr. Bugyi István Kórház, Sima Ferenc, Szentes, Hungary.
Joachim SieperCharité Universitätsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany.
Kara BickhamMerck & Co., Inc, Kenilworth, NJ, USA. kara.bickham@merck.com.
Anish MehtaMerck & Co., Inc, Kenilworth, NJ, USA.
Nancy FronteraMerck & Co., Inc, Kenilworth, NJ, USA.
Paul StryszakMerck & Co., Inc, Kenilworth, NJ, USA.
Zoran PopmihajlovMerck & Co., Inc, Kenilworth, NJ, USA.
Paul M PelosoMerck & Co., Inc, Kenilworth, NJ, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USCharité - Universitätsmedizin Berlin · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study evaluated two doses of etoricoxib (60 and 90 mg) vs. naproxen 1000 mg in subjects with ankylosing spondylitis (AS).

methodsThis was a 2-part, double-blind, active comparator-controlled non-inferiority study in subjects ≥18 years of age with AS. In Part I, subjects were randomized to naproxen 1000 mg; etoricoxib 60 mg, and 90 mg. In Part II, naproxen and etoricoxib 90 mg subjects continued on the same treatment; subjects on etoricoxib 60 mg either continued on 60 mg or escalated to 90 mg. Part I (6 weeks) assessed the efficacy of A) etoricoxib 60 mg vs. naproxen and B) 90 mg vs. naproxen according to the time-weighted average change from baseline in Spinal Pain Intensity (SPI; 0-100 mm VAS) (primary endpoint). The non-inferiority margin was set at 8 mm for SPI. In Part II (20 weeks) we evaluated the potential benefit of increasing from 60 to 90 mg (predefined minimum clinically important difference = 6 mm in SPI) for inadequate responders (<50 % improvement from baseline in SPI) on etoricoxib 60 mg in Part I.

resultsIn total, 1015 subjects were randomized to receive etoricoxib 60 mg (N = 702), etoricoxib 90 mg (N = 156), and naproxen 1000 mg (N = 157); 70.9 % were male and the mean age was 45.2 years. There were 919 subjects who completed Part I and all continued to Part II. In Part I, SPI change was non-inferior for both etoricoxib doses vs. naproxen. In both Part I and II, the incidence of adverse events (AEs), drug-related AEs, and serious adverse events (SAEs) were similar between the 3 treatment groups.

conclusionBoth doses of etoricoxib were non-inferior to naproxen. All treatments were well tolerated. Etoricoxib 60 and 90 mg effectively control pain in patients with AS, with 60 mg once daily as the lowest effective dose for most patients.

trial registrationClinical Trials Registry # NCT01208207 . Registered on 22 September 2010.

Indexed as

AdultAgedAged, 80 and overCyclooxygenase 2 InhibitorsDouble-Blind MethodEtoricoxibFemaleHumansMaleMiddle AgedNaproxenPainPain MeasurementPyridinesSpondylitis, AnkylosingSulfonesCyclooxygenase 2 InhibitorsEtoricoxibNaproxenPyridinesSulfonesAnkylosing spondylitisEtoricoxibNaproxenNSAIDsSpinal pain

Identifiers

PMID27737664
PMCPMC5062857
OpenAlexW2530826519

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.