Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR - Full Text View

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00216398

Purpose

The purpose of this study is to assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.

Condition	Intervention	Phase
Acromegaly	Drug: Lanreotide (Autogel formulation)	Phase IV

Drug Information available for: Octreotide Octreotide acetate Somatotropin Somatropin Lanreotide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase IV, Multicentre, Open-Label, Single Group Study to Evaluate the Dosing, Efficacy and Safety of Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

Further study details as provided by Ipsen:

Primary Outcome Measures:

The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit.

Secondary Outcome Measures:

The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit.
The percentage of patients with normalised IGF-1 compared to the baseline visit.
Change in the GH values compared to the baseline (Week 0) visit.
Change in the IGF-1 values compared to the baseline (Week 0) visit.
Change in serum lanreotide levels compared to the baseline (Week 0) visit.
Change in the serum octreotide levels compared to the baseline visit.
Patient evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
Investigator evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.

Estimated Enrollment:	8
Study Start Date:	June 2004
Estimated Study Completion Date:	December 2006

Eligibility

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

Criteria

Inclusion Criteria:

Clinical diagnosis of acromegaly
The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and shown to have a GH level <10 mU/L.
The patient must have been treated with a stable dose of octreotide LAR for at least four months prior to study entry
Life expectancy of at least 2 years

Exclusion Criteria:

Adenectomy within past 6 months, or likely during study period
Radiotherapy for acromegalic disease within 1 year, or likely during study period
Unstable concomitant dopamine agonist therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216398

Locations

Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Hugues Berard, MD

Ipsen

More Information

Study ID Numbers:	A-9B-52030-159
Study First Received:	September 13, 2005
Last Updated:	October 11, 2007
ClinicalTrials.gov Identifier:	NCT00216398
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Ipsen:

acromegaly
growth hormone

Study placed in the following topic categories:

Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Central Nervous System Diseases
Endocrine System Diseases
Octreotide
Angiopeptin

Brain Diseases
Bone Diseases
Lanreotide
Musculoskeletal Diseases
Endocrinopathy
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