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 ]

Hematology/blood chemistry - weekly, physical examinations - biweekly, vital signs - biweekly, urinalysis - monthly, ECG - monthly


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