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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00582426 |
This study will evaluate the efficacy of octreotide LAR in preventing diarrhea after chemotherapy (with regimens that contain 5 fluoracil, irinotecan and capecitabine).
Condition | Intervention | Phase |
---|---|---|
Chemotherapy-Induced Diarrhea |
Drug: Octreotide Long Active Release |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Factorial Assignment, Safety/Efficacy Study |
Official Title: | LARCID: Evaluation of Octreotide LAR in Prevention of Chemotherapy-Induced Diarrhea |
Estimated Enrollment: | 140 |
Study Start Date: | November 2007 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
prevention of CID
|
Drug: Octreotide Long Active Release |
2: No Intervention | Drug: Octreotide Long Active Release |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply.
Contact: Novartis | 41 61 324 1111 |
Argentina | |
Novartis Investigative Site | Not yet recruiting |
Buenos Aires, Argentina | |
Brazil | |
CEPON - Centro de Pesquisas Oncológicas | Not yet recruiting |
Florianópolis, Brazil | |
Principal Investigator: Lucilda Lima, M.D. | |
Hospital São Lucas - PUCRS | Recruiting |
Porto Alegre, Brazil | |
Principal Investigator: Carlos Barrios, M.D. | |
Instituto Arnaldo Vieira de Carvalho - IAVC | Recruiting |
São Paulo, Brazil | |
Principal Investigator: Brigitte Van Eyll, M.D. | |
Hospital A C Camargo/ Fundação Antonio Prudente | Recruiting |
São Paulo, Brazil | |
Principal Investigator: Marcello Fanelli, M.D. | |
Faculdade de Medicina do ABC | Recruiting |
Santo André, Brazil | |
Principal Investigator: Auro del Giglio, M.D. | |
Clínica AMO | Recruiting |
Salvador, Brazil | |
Principal Investigator: Carlos Sampaio Filho, M.D. | |
Hospital das Clínicas - FMUSP | Not yet recruiting |
São Paulo, Brazil | |
Principal Investigator: Daniel Saragiotto, M.D. | |
Mexico | |
Novartis Investigative Site | Recruiting |
Durango, Mexico | |
Novartis Investigative Site | Recruiting |
Mexico DF, Mexico |
Study Chair: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CSMS995AIC04 |
Study First Received: | December 21, 2007 |
Last Updated: | June 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00582426 |
Health Authority: | Brazil: ANVISA Agência Nacional de Vigilância Sanitária; México: COFEPRIS Comisión Federal para la Protección contra Riesgos Sanitarios; Argentina: ANMAT Administración Nacional de Medicamentos, Alimentos y Tecnología Médica |
Colorectal cancer diarrhea drug therapy octreotide |
fluorouracil irinotecan capecitabine prevention |
Signs and Symptoms Capecitabine Diarrhea Signs and Symptoms, Digestive |
Fluorouracil Irinotecan Octreotide Colorectal Neoplasms |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Gastrointestinal Agents Pharmacologic Actions |