Clinical Trial: Study of LX1606 in Subjects With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title:
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of LX1606 versus a placebo control in subjects with symptomatic carcinoid syndrome not managed by stable-dose long-acting octreotide therapy. Following determination of the maximally tolerated or effective dose, cohort expansion will occur to confirm effect on symptoms and safety profile.
Detailed Summary:
Sponsor: Lexicon Pharmaceuticals
Current Primary Outcome: Safety (physical examinations, clinical laboratory tests, vitals signs measurements, and ECGs) [ Time Frame: Weekly and biweekly ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Symptom diary [ Time Frame: Daily ]
- Effectiveness (number of bowel movements compared to baseline) [ Time Frame: Daily ]
- Subjective global assessment [ Time Frame: Weekly ]
- Effect on biomarker levels in blood (5-HT) [ Time Frame: Weekly ]
- Effect on biomarker levels in urine (5-HIAA) [ Time Frame: Biweekly ]
- Chromogranin-A levels in blood [ Time Frame: Biweekly ]
Original Secondary Outcome: Same as current
Information By: Lexicon Pharmaceuticals
Dates:
Date Received: February 25, 2009
Date Started: March 2009
Date Completion:
Last Updated: April 1, 2016
Last Verified: April 2016