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Phase II Study With ITF2984 in Acromegalic Patients

NCT02111044 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2016-06-16

No results posted yet for this study

Summary

The purpose of this study is to investigate in acromegalic patients the effect of different doses of ITF2984 on GH and IGF-1 concentrations and to investigate safety and tolerability of three different doses of ITF2984.

Conditions

Interventions

DRUG

Octreotide

octreotide 100 mcg sc t.i.d. for 4 weeks

DRUG

ITF2984 500 mcg

ITF2984 500 mcg sc b.i.d for 4 weeks

DRUG

ITF2984 1000 mcg

ITF2984 1000 mcg sc b.i.d for 4 weeks

DRUG

ITF2984 2000 mcg

ITF2984 2000 mcg sc b.i.d for 4 weeks

Sponsors & Collaborators

  • Italfarmaco

    lead INDUSTRY

Principal Investigators

  • Paolo Bettica, MD · Italfarmaco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Czechia
  • France
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Romania
  • Serbia
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT02111044 on ClinicalTrials.gov