Clinical Trial: Study of LX1606 in Subjects With Symptomatic Carcinoid Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2, Open-Label, Multi-Center, Serial Ascending Dose, Dose-Finding Study to Evaluate the Safety and Tolerability of LX1606 in Subjects With Symptomatic Carcinoid Syndrome
Brief Summary: The purpose of the study is to evaluate the safety and tolerability of multi-dose, open-label LX606 in subjects with symptomatic carcinoid syndrome.
Detailed Summary:
Sponsor: Lexicon Pharmaceuticals
Current Primary Outcome: Safety (physical examinations, clinical laboratory tests, vital signs measurements, and ECGs) [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of bowel movements [ Time Frame: 12 weeks ]
- Flushing episodes [ Time Frame: 12 weeks ]
- Subjective global assessment [ Time Frame: 12 weeks ]
- Urgency to defecate [ Time Frame: 12 weeks ]
- Stool form/consistency [ Time Frame: 12 weeks ]
- Blood 5-HT levels [ Time Frame: 12 weeks ]
- Blood Chromagranin-A levels [ Time Frame: 12 weeks ]
- Urinary 5-HIAA levels [ Time Frame: 12 weeks ]
- Sensation/severity of nausea [ Time Frame: 12 weeks ]
- Abdominal pain and discomfort [ Time Frame: 12 weeks ]
Original Secondary Outcome: Same as current
Information By: Lexicon Pharmaceuticals
Dates:
Date Received: April 12, 2010
Date Started: May 2010
Date Completion:
Last Updated: April 1, 2016
Last Verified: April 2016