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Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly

NCT00372697 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2011-05-17

Study results available
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Summary

This study evaluated the safety and efficacy of an increased frequency of octreotide acetate injections or an increase in dose in partially responsive acromegalic patients with persistently uncontrolled disease.

Conditions

Interventions

DRUG

Octreotide acetate 30 mg suspension

Each vial of study medication contained octreotide acetate 30 mg in a microencapsulated biodegradable polymer, poly (DL-lactide-co-glycolide) (D-(+)glucose), with 17% w/w mannitol in an approximate octreotide:polymer ratio of 1:20. The vehicle contained 0.5% sodium carboxymethylcellulose.

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • Italy

Study Locations

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Entities

Diseases
Companies

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 NCT00372697 on ClinicalTrials.gov