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NCT01677910 · ClinicalTrials.gov registry record · Phase 3
TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
A Phase 3 study of Carcinoid Syndrome, sponsored by Lexicon Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 135
- Enrollment target
- 20
- Study locations
NCT01677910: Completed Phase 3 study of Carcinoid Syndrome, sponsored by Lexicon Pharmaceuticals.
NCT01677910 is a Phase 3 study of Carcinoid Syndrome that has completed, run by Lexicon Pharmaceuticals. The registered enrollment target is 135 participants, above the 110-participant average among 4 other Carcinoid Syndrome trials with a reported enrollment target (23% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01677910, a Phase 3 study of Carcinoid Syndrome, has completed, sponsored by Lexicon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 135 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.
Conditions Studied
Interventions
- DRUG Telotristat etiprate
- DRUG Placebo-matching telotristat etiprate
Study Locations (20)
Texas
- Lexicon Investigational Site - Fort Worth
- Lexicon Investigational Site - Houston
- Lexicon Investigational Site - McAllen
California
- Lexicon Investigational Site - Palo Alto
- Lexicon Investigational Site - San Francisco
Massachusetts
- Lexicon Investigational Site - Boston
- Lexicon Investigational Site - Boston
New York
- Lexicon Investigational Site - Buffalo
- Lexicon Investigational Site - New York
New South Wales
- Lexicon Investigational Site - Kogara
- Lexicon Investigational Site - Saint Leanoards
Alabama
- Lexicon Investigational Site - Mobile
Florida
- Lexicon Investigational Site - Orlando
Iowa
- Lexicon Investigational Site - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2013-01-08 |
| Est. Completion | 2016-03-21 |
| Phase | Phase 3 |
What the finished NCT01677910 record still lists
NCT01677910 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, above the 110-participant average among 4 other Carcinoid Syndrome trials with a reported enrollment target (23% higher).
The record links to 1 condition, with Carcinoid Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Telotristat etiprate is the first listed.
NCT01677910 names 20 study sites across 14 states, led by Texas, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01677910 about?
NCT01677910 is a clinical study titled "TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)". 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 a...
What is the current status of trial NCT01677910?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 135 participants. The study started on 2013-01-08. Estimated completion is 2016-03-21.
What conditions does trial NCT01677910 study?
This clinical trial studies the following conditions: Carcinoid Syndrome.
What interventions are being tested in trial NCT01677910?
The interventions under investigation include: Telotristat etiprate (DRUG), Placebo-matching telotristat etiprate (DRUG).
Who is sponsoring clinical trial NCT01677910?
This trial is sponsored by Lexicon Pharmaceuticals, which has 56 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01677910 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Iowa, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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