drugset / Trial / NCT00050635

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

NCT00050635

Phase 4 Completed 150 enrolled Novartis Pharmaceuticals Quintiles, Inc. · collab
RandomizedParallel-groupOpen-labelPrevention

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

Timeline

Start
2002-12
Primary completion
Completion
2003-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Octreotide Peptide 30 mg
Subject Octreotide Peptide 40 mg