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Extended-release of Octreotide (LF-PB) for the Treatment of Seroma

NCT02668588 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-02-02

No results posted yet for this study

Summary

This is a multicentre, double blind, randomized placebo controlled trial to assess the effect of LF-PB on seroma formation in women with breast cancer undergoing Axillary Lymph Node Dissection (ALND).

Recruited patients will be randomly assigned to receive LF-PB 30 mg or placebo.

Conditions

  • Seroma

Interventions

DRUG

extended release of octreotide

1 intramuscular injection of extended release of octreotide 30 mg

DRUG

extended release of placebo

1 intramuscular injection of extended release of placebo

Sponsors & Collaborators

  • Chemi S.p.A.

    lead INDUSTRY

Principal Investigators

  • Paolo Carcoforo, Prof. · U.O. Clinica Chirurgica, A. O. Univ. Arcispedale S.Anna - Ferrara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-22
Primary Completion
2016-07-19
Completion
2016-07-19

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02668588 on ClinicalTrials.gov