Trial reportClinical therapeutics2016
Patient-reported Symptom Experiences in Patients With Carcinoid Syndrome After Participation in a Study of Telotristat Etiprate: A Qualitative Interview Approach.
Trial report in Clinical therapeutics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00853047 (A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Ascending, Multidose Study To Determine Safety and Tolerability of Orally Administered LX1606 in Subjects With Symptomatic Carcinoid Syndrome Refractory to Stable-Dose Octreotide Long-Acting Release Depot Therapy), which is not on this map. Cited by 31 papers, 3 of them syntheses that pooled 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.
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.
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Ascending, Multidose Study To Determine Safety and Tolerability of Orally Administered LX1606 in Subjects With Symptomatic Carcinoid Syndrome Refractory to Stable-Dose Octreotide Long-Acting Release Depot Therapy
Who cites it
31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 47 citations in OpenAlex.
- A Systematic Review of Economic and Quality-of-Life Research in Carcinoid Syndrome.PharmacoEconomics · 2021Pooled it
- Quality of life in patients with gastroenteropancreatic tumours: A systematic literature review.World journal of gastroenterology · 2020Pooled it
- Systematic review reveals lack of quality in reporting health-related quality of life in patients with gastroenteropancreatic neuroendocrine tumours.Health and quality of life outcomes · 2016Pooled it
- Estimation of minimally important differences and responder definitions for EORTC QLQ-MY20 scores in multiple myeloma patients.European journal of haematology · 2019Trial
- Trial
- Exit Interviews Examining Patient Experiences with Tirzepatide and Dulaglutide for Treatment of Type 2 Diabetes in the SURPASS-CVOT Trial.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026Article
- Beyond Numbers: Uses and Value of In-Trial Interview Data for Regulatory and Health Technology Assessment (HTA) Decision Making.The patient · 2026Review
- Qualitative In-trial Interviews: Methods, Challenges, and Best Practice.The patient · 2025Article
- Exit Interviews Exploring Patients' Experience of Change in Crohn's Disease Symptoms During the Mirikizumab Phase 3 Clinical Trial In Adult Patients With Moderately-to-Severely Crohn's Disease.Crohn's & colitis 360 · 2025Article
- Establishing the Minimally Important Difference for the KOOS-Joint Replacement and PROMIS Global-10 in Patients After Total Knee Arthroplasty.Orthopaedic journal of sports medicine · 2024Article
- Using qualitative methods to establish the clinically meaningful threshold for treatment success in alopecia areata.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023Article
- Integrating qualitative interviews in drug development and the use of qualitative evidence in product labelling and health technology assessments: a review.Frontiers in medicine · 2023Review
- Exit Interviews Examining the Patient Experience in Clinical Trials of Tirzepatide for Treatment of Type 2 Diabetes.The patient · 2022Article
- Review
- A Multinational Pilot Study on Patients' Perceptions of Advanced Neuroendocrine Neoplasms on the EORTC QLQ-C30 and EORTC QLQ-GINET21 Questionnaires.Journal of clinical medicine · 2022Article
- Long-Term Treatment with Telotristat Ethyl in Patients with Carcinoid Syndrome Symptoms: Results from the TELEPATH Study.Neuroendocrinology · 2022Article
- Physician-perceived utility of the EORTC QLQ-GINET21 questionnaire in the treatment of patients with gastrointestinal neuroendocrine tumours: a multicentre, cross-sectional survey (QUALINETS).Health and quality of life outcomes · 2021Observational
- Management of Diarrhea in Patients With Carcinoid Syndrome.Pancreas · 2019Article
- Living With Neuroendocrine Tumors: Assessment of Quality of Life Through a Mobile Application.JCO clinical cancer informatics · 2019Article
- The Case for the Use of Patient and Caregiver Perception of Change Assessments in Rare Disease Clinical Trials: A Methodologic Overview.Advances in therapy · 2019Review
Corrections and comments
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Authors and funding
11 authors at 4 institutions in 1 country.
Funding
Abstract
purposeTelotristat etiprate, a tryptophan hydroxylase inhibitor, was previously evaluated in a Phase II randomized, placebo-controlled clinical trial in patients with carcinoid syndrome (CS) and diarrhea not adequately controlled by octreotide. The objective of the current study was to characterize the symptom experiences of patients participating in that trial.
methodsConsenting patients participated in one-on-one, qualitative interviews focused on eliciting symptoms they had experienced in association with their CS diagnosis and recollection of symptom changes they experienced while participating in the Phase II trial.
findingsAmong the 23 patients who participated in the previous 4-week dose-escalation study, 16 were eligible for interviews and 11 participated in the present study. The median time from study completion to the interview was 31 months; 4 of 11 patients were receiving telotristat etiprate in a follow-up, open-label trial at the time of interview. All of the patients (100%) described diarrhea as a symptom of CS, with effects on the emotional, social, and physical aspects of their lives. Improvement in diarrhea during the study was described by 82% of participants, and was very impactful in several patients. Results led to the design and implementation of a larger interview program in Phase III and helped to establish a definition of clinically meaningful change for the clinical development program. IMPLICATIONS: The diarrhea associated with CS can have a large impact on daily lives, and patient interviews can characterize and capture clinically meaningful improvements with treatment. ClinicalTrials.gov Identifier: NCT00853047.
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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.