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Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome

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ClinicalTrials.gov Identifier: NCT00884715
Recruitment Status : Terminated (Program was terminated for business reasons)
First Posted : April 21, 2009
Last Update Posted : September 20, 2013
Sponsor:
Information provided by (Responsible Party):

April 20, 2009
April 21, 2009
September 20, 2013
July 2009
November 2011   (Final data collection date for primary outcome measure)
Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea [ Time Frame: 9 months ]
Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00884715 on ClinicalTrials.gov Archive Site
safety and tolerability of the implants [ Time Frame: 9 months ]
safety and tolerability of the implants [ Time Frame: 6 months ]
Not Provided
Not Provided
 
Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome
Open Label Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Two Doses of an Octreotide Implant in Patients With Carcinoid Syndrome
Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment of the symptoms of carcinoid syndrome.
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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoid Syndrome
Drug: Octreotide
short acting octreotide
  • Experimental: 1 implant
    117 mg Octreotide implant
    Intervention: Drug: Octreotide
  • Experimental: 2 implants
    234 mg Octreotide implant
    Intervention: Drug: Octreotide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
December 2011
November 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • histologically confirmed tumor
  • documented evidence of carcinoid syndrome
  • life expectancy of at least 6 months
  • previous positive octreotide scan
  • received stable doses of octreotide injections
  • performance status of 0-2 on the ECOG performance scale

Exclusion Criteria:

  • poorly differentiated or high grade neuroendocrine tumor
  • significant cv, hepatic, renal or other disease
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00884715
IP107-002
No
Not Provided
Not Provided
Endo Pharmaceuticals
Endo Pharmaceuticals
Not Provided
Not Provided
Endo Pharmaceuticals
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP