Clinical Trial: Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Open Label Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Two Doses of an Octreotide Implant in Patients With Carcinoid Syndrome
Brief Summary: Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment of the symptoms of carcinoid syndrome.
Detailed Summary: This study will evaluate a longer acting octreotide formulation. A subcutaneous implant at 2 doses will be evaluated for pharmacodynamics, efficacy and safety for a period of 9 months.
Sponsor: Endo Pharmaceuticals
Current Primary Outcome: Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea [ Time Frame: 9 months ]
Original Primary Outcome: Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea [ Time Frame: 6 months ]
Current Secondary Outcome: safety and tolerability of the implants [ Time Frame: 9 months ]
Original Secondary Outcome: safety and tolerability of the implants [ Time Frame: 6 months ]
Information By: Endo Pharmaceuticals
Dates:
Date Received: April 20, 2009
Date Started: July 2009
Date Completion:
Last Updated: September 17, 2013
Last Verified: September 2013