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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00234572
First Posted: October 7, 2005
Last Update Posted: November 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ipsen
  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
Intervention Model: Parallel Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: October 6, 2005
First Posted: October 7, 2005
Last Update Posted: November 17, 2009
Last Verified: November 2009

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
Somatostatin
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs