STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea - Tabular View

Tracking Information
First Received Date ^ICMJE	December 17, 2002
Last Updated Date	September 21, 2009
Start Date ^ICMJE	December 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: May 24, 2006)	Change from baseline and at 6 months in the proportion of patients with NCI Grades 3 and/or 4 diarrhea during chemotherapy
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00050635 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	STOP Trial - Sandostatin LAR Depot Trial for the Optimum Prevention of Chemotherapy Induced Diarrhea
Official Title ^ICMJE
Brief Summary	Currently there is an ongoing clinical trial for patients with chemotherapy induced diarrhea. This trial is being conducted to evaluate the efficacy of two dose levels (30 mg and 40 mg) of an investigational drug in reducing the occurrence of severe (Grade 3 or 4) diarrhea during chemotherapy. Eligible patients must either have experienced NCI Common Toxicity Grade 1 - 4 chemotherapy-induced diarrhea during previous chemotherapy treatment or be experiencing Grade 1-4 chemotherapy-induced diarrhea currently. In order to participate in this clinical trial, patients must be male or female 18 years of age or older. Inclusion into this investigational drug trial is based on the protocol entry criteria and a detailed evaluation from a participating trial investigator
Detailed Description
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Neoplasms Diarrhea
Intervention ^ICMJE	Drug: Sandostatin LAR Depot
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	150
Completion Date	July 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	Key Inclusion criteria: male or female patients of 18 years of age or older, scheduled or expected to receive at least two cycles of chemotherapy over at least a two- month period as primary or adjuvant therapy for any malignancy, have experienced NCI Common Toxicity Grade 1 - 4 diarrhea during previous chemotherapy treatment or are currently experiencing Grade 1-4 diarrhea due to chemotherapy treatment Key Exclusion criteria: females who are pregnant or lactating, current use of anticoagulants, except for those who are receiving 1 mg/per day of Coumadin for port maintenance, known hypersensitivity to Sandostatin, Sandostatin LAR ® Depot or other related drug or compound, history or presence of Crohn™s disease, ulcerative colitis, sprue, or known C. difficile infection, or any other diarrheal syndrome, WBC < 3000 /L, Platelets < 75,000 /L, serum creatinine >2.0 mg/dL
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00050635
Responsible Party
Study ID Numbers ^ICMJE	CSMS995AUS38, STOP Trial
Study Sponsor ^ICMJE	Novartis Pharmaceuticals
Collaborators ^ICMJE	Quintiles
Investigators ^ICMJE
Information Provided By	Novartis
Verification Date	March 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP