Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly - Full Text View

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00234572

Purpose

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.

Condition	Intervention	Phase
Acromegaly	Drug: Lanreotide (Autogel formulation)	Phase II Phase III

Drug Information available for: Lanreotide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II, Multicentre, Randomized, Double-Blind Study in Acromegalic Patients Evaluating the Efficacy and Safety of a Single Deep Subcutaneous Administration of Lanreotide Autogel (60, 90 or 120mg) Versus Placebo Followed by a Single Blind Fixed Dose Phase Evaluating the Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Profile of Multiple Deep Subcutaneous Administrations of Lanreotide Autogel (60, 90 & 120mg) Ending in Open Label Dose Titration Phase.

Further study details as provided by Ipsen:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	96
Study Start Date:	May 2000
Estimated Study Completion Date:	January 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234572

Show 29 Study Locations

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

France Catus, MD

Ipsen

More Information

Study ID Numbers:	E-28-52030-717
Study First Received:	October 6, 2005
Last Updated:	April 12, 2006
ClinicalTrials.gov Identifier:	NCT00234572
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bone Diseases, Endocrine
Hypothalamic Diseases
Lanreotide
Pituitary Diseases
Musculoskeletal Diseases
Angiopeptin

Endocrine System Diseases
Central Nervous System Diseases
Endocrinopathy
Brain Diseases
Bone Diseases
Acromegaly

Additional relevant MeSH terms:

Hyperpituitarism
Antineoplastic Agents
Therapeutic Uses

Nervous System Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009