Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly

Phase 2

Completed

• Conditions: Acromegaly

• Registration Number: NCT00234572
• Lead Sponsor: Ipsen

Brief Summary

The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo after a single injection. Effectiveness and safety were then also assessed following four fixed-dose injections and after one year of treatment given at titrated doses.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05
• Primary Completion: 2003-01-03
• Study Completion: 2003-01-03
• Study First Submitted: 2005-10-06
• Study First Submitted QC: 2005-10-06
• Study First Posted: 2005-10-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• documentation of a diagnosis of active acromegaly based on either of the following definitions:

  1. the patient has never received somatostatin analog nor dopaminergic agonist or had previously received this medication but had stopped more than 3 months before visit 1 and had a mean growth hormone (GH)level >5ng/mL at visit 1; or
  2. the patient was receiving treatment with a somatostatin analog (other than lanreotide autogel) or a dopaminergic agonist at visit 1, had a mean GH >3ng/mL at visit 2 (or visit 2a) and had at least a 100% increase in mean GH levels between visit 1 and visit 2 (or visit 2a)

Exclusion Criteria

• receipt of radiotherapy for acromegaly within 3 years
• pituitary surgery within 3 months prior to visit 1
• prior receipt of lanreotide autogel or GH antagonist
• anticipated need for pituitary surgery (adenomectomy) or radiotherapy during the study period
• known hypersensitivity to any of the test materials or related compounds
• clinically significant renal or hepatic abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean serum GH levels determined from serial measurements at screening, weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal

Secondary Outcome Measures

Name	Time	Method
Serum IGF-1 levels determined at screening, at weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal

Trial Locations

Locations (29)

Baptist Health System Inc; 🇺🇸 Birmingham, Alabama, United States

Pituitary Center; 🇺🇸 Los Angeles, California, United States

Northwestern Medical Facility; 🇺🇸 Chicago, Illinois, United States

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States

New York University Medical Center; 🇺🇸 New York, New York, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Oregon Health Sciences University; 🇺🇸 Portland, Oregon, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

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