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

Phase 4

Completed

• Conditions: Neoplasms; Diarrhea

• Registration Number: NCT00050635
• Lead Sponsor: Novartis Pharmaceuticals

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

Not available

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2002-12-17
• Study First Submitted QC: 2002-12-17
• Study First Posted: 2002-12-18
• Study Completion: 2003-07
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-18
• Last Update Posted: 2009-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline and at 6 months in the proportion of patients with NCI Grades 3 and/or 4 diarrhea during chemotherapy

Trial Locations

Locations (33)

Kenmar Research Institute; 🇺🇸 Los Angeles, California, United States

Bay Area Cancer Research Group; 🇺🇸 Concord, California, United States

Compassionate Cancer Care medical Group, Inc.; 🇺🇸 Fountain Valley, California, United States

California Cancer Care, Inc.; 🇺🇸 Greenbrae, California, United States

Pacific Shores Medical Center; 🇺🇸 Long Beach, California, United States

Oncology Hematology Group of South Florida; 🇺🇸 Miami, Florida, United States

Pasco Hernando Oncology Associates; 🇺🇸 New Port Richey, Florida, United States

Mid-Florida Hematology & Oncology Centers, PA; 🇺🇸 Orange City, Florida, United States

Oncology & Hematology Associates of West Broward; 🇺🇸 Tamarac, Florida, United States

Creticos Cancer Center; 🇺🇸 Chicago, Illinois, United States

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