Evidence map›Paper›PMID 32734461›Full record

Trial reportWorld journal of urology2021

An adaptive randomized clinical trial in interstitial cystitis/bladder pain syndrome evaluating efficacy of ASP3652 and the relationship between disease characteristics and Hunner's lesions.

Jos G A Houbiers, J W Olivier van Till, Mathilde Kaper, Yalcin Yavuz, Reynaldo V Martina, Dirk Cerneus, Joost Melis, Otto Stroosma, J Curtis Nickel, Phil M Hanno and 1 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in World journal of urology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Jos G A Houbiers *Astellas Pharma Europe B.V, Leiden, The Netherlands.
J W Olivier van Till *Astellas Pharma Europe B.V, Leiden, The Netherlands. olivier.vantill@astellas.com.ORCID http://orcid.org/0000-0002-2395-9332
Mathilde KaperAstellas Pharma Europe B.V, Leiden, The Netherlands.
Yalcin YavuzAstellas Pharma Europe B.V, Leiden, The Netherlands.
Reynaldo V MartinaAstellas Pharma Europe B.V, Leiden, The Netherlands.
Dirk CerneusAstellas Pharma Europe B.V, Leiden, The Netherlands.
Joost MelisAstellas Pharma Europe B.V, Leiden, The Netherlands.
Otto StroosmaAstellas Pharma Europe B.V, Leiden, The Netherlands.
J Curtis NickelDepartment of Urology, Queens University, Kingston, Canada.
Phil M HannoDepartment of Urology, Stanford University, Stanford, CA, USA.
Jørgen NordlingDepartment of Urology, University of Copenhagen, Copenhagen, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe primary purpose of this study was to evaluate the effect of the fatty acid amide hydrolase (FAAH) inhibitor ASP3652 on efficacy and safety in patients with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). The secondary purpose was to evaluate phenotyping based on Hunner's lesions (HL).

methodsIn this randomized trial, adult female patients with moderate/severe IC/BPS received 12 weeks of treatment with an oral dose of ASP3652 (50, 150, or 300 mg twice daily) or placebo. A Bayesian model was employed using accumulating data to adjust the randomization probability and to analyze the primary efficacy variable (change from baseline to end of treatment in Mean Daily Pain [MDP; range 0-10]). Study outcomes and patient characteristics of patients with and without HL (HL+ and HL-) were compared.

resultsIn total, 287 patients were randomized. The 300 mg dose group (n = 97) showed the largest effect, i.e., a mean change from baseline to end of treatment of -1.73 in MDP. However, the mean difference from placebo was 0.02. The probability that this dose was better than placebo was 13.5%. Adverse event incidence was low and similar between study groups. HL+ patients were older and had more severe symptoms than HL-. An association was suggested in HL+ patients between changes in micturition frequency and MDP (R = 0.41 [95% CI 0.18, 0.63]), which was not observed in HL- (R = 0.04 [95% CI -0.16, 0.29]).

conclusionASP3652 was safe and well tolerated, but did not show efficacy in IC/BPS. The observed differences between HL+ and HL- suggest that IC/BPS diagnosis and treatment may be approached differently in these two phenotypes.

trial registrationEudraCT number 2011-004555-39, date of registration: 2012-05-07.

Indexed as

AdultAgedAmidohydrolasesCystitis, InterstitialDouble-Blind MethodFatty Acid Amide HydrolasesFemaleHumansMiddle AgedOrganic ChemicalsTreatment OutcomeUlcerUrinary Bladder DiseasesAmidohydrolasesASP3652Fatty Acid Amide HydrolasesOrganic ChemicalsEndocannabinoidsFatty acid amide hydrolase (FAAH) inhibitorHunner’s lesionInterstitial cystitisPatient characteristicsPhenotype

Identifiers

PMID32734461

What OpenQuestion holds

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Registered trials

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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.