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

NCT01754285 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2014-07-29

No results posted yet for this study

Summary

This is a phase II, multicenter, double-blind, double-dummy, parallel-group, placebo-controlled, study to evaluate LF-PB versus placebo in female patients with brest cancer who are undergoing breast surgery with axillary lymphnode dissection.

Recruited patients will be randomly assigned to one of the following treatment groups: Placebo, LF-PB 10 mg, LF-PB 20 mg and LF-PB 30 mg.

Mode of administration is single intramuscular (IM) injection so the treatments arms are as follows:

Placebo: 2 injections of placebo LF-PB 10 mg: 2 injections = placebo + 10 mg LF-PB 20 mg: 2 injections = placebo + 20 mg LF-PB 30 mg: 2 injections = 10 mg + 20 mg

The study will randomize a total of 120 patients (30 per arm) in about 10 Italian Sites.

Conditions

  • Lymphorrhea

Interventions

DRUG

LF-PB and Placebo

DRUG

Placebo

DRUG

LF-PB

Sponsors & Collaborators

  • Chemi S.p.A.

    lead INDUSTRY

Principal Investigators

  • Paolo Carcoforo, MD · Clinica Chirurgica, Azienda Ospedaliero-Universitaria Arcispedale "S. Anna" Ferrara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

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 NCT01754285 on ClinicalTrials.gov