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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00234572
First received: October 6, 2005
Last updated: November 16, 2009
Last verified: November 2009
History of Changes
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

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

Publications:

ClinicalTrials.gov Identifier: NCT00234572     History of Changes
Other Study ID Numbers: E-28-52030-717
Study First Received: October 6, 2005
Last Updated: November 16, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Endocrine System Diseases
Lanreotide
Angiopeptin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013