ReviewGastroenterology report2015
Development of drugs for celiac disease: review of endpoints for Phase 2 and 3 trials.
Review in Gastroenterology report, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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.
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.
Who cites it
20 citing papers in PubMed, 52 citations in OpenAlex.
- Latiglutenase Improves Symptoms in Seropositive Celiac Disease Patients While on a Gluten-Free Diet.Digestive diseases and sciences · 2017Trial
- Psychometric testing of the ICECAP-A in patients with coeliac disease: a comparative analysis with EQ-5D-5L.Health and quality of life outcomes · 2025Article
- A feasibility study using quantitative and interpretable histological analyses of celiac disease for automated cell type and tissue area classification.Scientific reports · 2024Article
- Development of the celiac disease symptom diary version 2.1Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024Article
- Rapid discovery of Transglutaminase 2 inhibitors for celiac disease with boosting ensemble machine learning.Computational and structural biotechnology journal · 2024Article
- Pathologist-trained machine learning classifiers developed to quantitate celiac disease features differentiate endoscopic biopsies according to modified marsh score and dietary intervention response.Diagnostic pathology · 2023Article
- Health utilities and willingness to pay in adult patients with coeliac disease in Hungary.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023Article
- Review
- Society for the Study of Celiac Disease position statement on gaps and opportunities in coeliac disease.Nature reviews. Gastroenterology & hepatology · 2021Article
- New Insights into Non-Dietary Treatment in Celiac Disease: Emerging Therapeutic Options.Nutrients · 2021Review
- Latiglutenase Treatment for Celiac Disease: Symptom and Quality of Life Improvement for Seropositive Patients on a Gluten-Free Diet.GastroHep · 2019Article
- Celiac disease: a comprehensive current review.BMC medicine · 2019Review
- Quantitative histology-based classification system for assessment of the intestinal mucosal histological changes in patients with celiac disease.Intestinal research · 2019Article
- Quality of life in coeliac disease: item reduction, scale development and psychometric evaluation of the Coeliac Disease Assessment Questionnaire (CDAQ).Alimentary pharmacology & therapeutics · 2018Article
- Article
- Quality of life in coeliac disease: qualitative interviews to develop candidate items for the Coeliac Disease Assessment Questionnaire.Patient related outcome measures · 2018Article
- Value of IgA tTG in Predicting Mucosal Recovery in Children With Celiac Disease on a Gluten-Free Diet.Journal of pediatric gastroenterology and nutrition · 2017Article
- Innate immunity: actuating the gears of celiac disease pathogenesis.Best practice & research. Clinical gastroenterology · 2015Review
- What is the best histopathological classification for celiac disease? Does it matter?Gastroenterology and hepatology from bed to bench · 2015Article
- The Progression of Celiac Disease, Diagnostic Modalities, and Treatment Options.Journal of investigative medicine high impact case reportsReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Celiac disease is a lifelong disorder for which there is currently only one known, effective treatment: a gluten-free diet. New treatment approaches have recently emerged; several drugs are in Phase 2 trials and results appear promising; however, discussion around regulatory endpoints is in its infancy. We will briefly discuss the drugs that are under development and then shift our attention to potential trial endpoints, such as patient-reported outcomes, histology, serology, gene expression analysis and other tests. We will outline the differing requirements for proof-of-concept Phase 2 trials and Phase 3 registration trials, with a particular emphasis on current thinking in regulatory agencies. We conclude our paper with recommendations and a glossary of regulatory terms, to enable readers who are less familiar with regulatory language to take maximum advantage of this review.
Indexed as
Identifiers
What OpenQuestion holds
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.