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Serotonin Syndrome clinical trials

View clinical trials related to Serotonin Syndrome.

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NCT ID: NCT03722511 Completed - Diarrhea Clinical Trials

Evaluating an Amino Acid Based Medical Food w/ Diarrhea in Carcinoid Syndrome & Other NETs

Start date: December 6, 2018
Phase: Phase 2
Study type: Interventional

Primary Objective: To assess how an amino acid based medical food (Enterade®) helps maintain the intestine's ability to absorb and retain fluids, leading to a reduction in diarrhea due to Neuroendocrine Tumors (NET) and/or Carcinoid Syndrome. This improvement in the absorption will be assessed in part by evaluating changes in average daily stool frequency from baseline in patients receiving Enterade®. Each subject serves as his or her own control. Secondary Objectives: - To assess subject reported health-related quality of life in subjects before and after compound administration. - To characterize the side effect profile and tolerability of Enterade® as measured by the number of total 8-oz Enterade® bottles consumed throughout the trial, and average drinks per day. - To evaluate changes in serum electrolytes before and after administration of Eenterade®. - To assess intravenous fluid requirement and/or hospitalization for dehydration secondary to diarrhea between control observation period and active Enterade® period. - To evaluate difference in utilization of standard-of-care anti-diarrheal medications between control observation period and Enterade® period. - To compare subjective feeling of bloating and flatulence before and after administration of Enterade®. - To evaluate changes in patient weight before and after administration of Enterade®.

NCT ID: NCT03223428 Completed - Carcinoid Syndrome Clinical Trials

Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO

RELAX
Start date: June 22, 2017
Phase:
Study type: Observational [Patient Registry]

The primary objective of the study is to estimate the proportion of carcinoid syndrome (CS) patients who are satisfied with their overall symptom control, 6 months after initiating treatment with telotristat ethyl (XERMELO).

NCT ID: NCT03220087 Completed - Clinical trials for Neuroendocrine Tumors

Study to Evaluate the Use of Resources and the Costs Associated With Carcinoid Syndrome (CS) in Patients With NETs in Spain

RECOSY
Start date: July 21, 2017
Phase:
Study type: Observational

The objective of this study is to describe the use of resources and the costs associated with controlled or uncontrolled CS in patients with NETs in Spain.

NCT ID: NCT02063659 Completed - Carcinoid Syndrome Clinical Trials

Telotristat Etiprate for Carcinoid Syndrome Therapy

TELECAST
Start date: March 11, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA) levels.

NCT ID: NCT02026063 Completed - Carcinoid Syndrome Clinical Trials

Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms

TELEPATH
Start date: January 14, 2014
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.

NCT ID: NCT01932528 Completed - Carcinoid Syndrome Clinical Trials

An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males

LX1606-104
Start date: August 2013
Phase: Phase 1
Study type: Interventional

To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and its primary metabolite LX1033.

NCT ID: NCT01677910 Completed - Carcinoid Syndrome Clinical Trials

TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)

Start date: January 8, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.

NCT ID: NCT01430871 Completed - Carcinoid Syndrome Clinical Trials

Effects of Serotonin Excess on Bone in Carcinoid Syndrome

Start date: January 2011
Phase: N/A
Study type: Observational

Serotonin has recently been identified as a major regulator of bone formation. Gut-derived serotonin inhibits bone formation, and early animal studies have shown that inhibition of gut-derived serotonin has anabolic effects on bone in ovariectomised rodents. This pathway has potential to be developed as a new anabolic treatment for osteoporosis in humans. Carcinoid neuro-endocrine tumours produce very high levels of serotonin, and so it might be expected that patients with carcinoid disease would have reduced bone formation, low bone mass and fractures. However, this has not been apparent in clinical practice. There may be a discrepancy between rodent models and human disease. This study aims to identify whether patients with carcinoid disease have reduced bone mass, reduced bone formation or high fracture rates. The investigators will conduct a cross-sectional observational case-control study of patients with carcinoid disease in the Sheffield neuro-endocrine tumour clinic and gender-, age- and body mass index (BMI)-matched controls.

NCT ID: NCT01234168 Completed - Clinical trials for Neuroendocrine Tumors

A Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea

SYMNET
Start date: October 2010
Phase:
Study type: Observational

The purpose of the protocol is to to assess subject's overall satisfaction regarding control of diarrhea. The study aims to supplement results obtained through clinical trials with data obtained from a population of patients receiving treatment with Somatuline Autogel in routine practice.

NCT ID: NCT01104415 Completed - Carcinoid Syndrome Clinical Trials

Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome

Start date: June 15, 2010
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety and tolerability of orally administered telotristat etiprate (LX1606) in participants with symptomatic carcinoid syndrome.