Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00145405
First received: September 2, 2005
Last updated: September 6, 2006
Last verified: September 2005
  Purpose

The morbidity and the mortality in acromegalic patients closely correspond to growth hormone (GH) levels and therefore efficient long-term treatment is important.

Neurosurgery is the first choice of treatment in acromegalic patients. Surgery normalizes GH levels in about 80% of patients with microadenomas, but less than 50 % of patients with macroadenomas respond sufficiently to surgery alone. In most patients, additional medical therapy is therefore needed.

Somatostatin analogues have successfully been used in treatment of acromegaly if surgery or radiotherapy can not lead to normal GH and IGF-I levels. Lanreotide Autogel (LAN) is a new formulation of lanreotide consisting of a prolonged release aqueous formulation, which can be injected intramuscularly or deep subcutaneously once every 28 days.

Aim

The aim of the present study was to compare the efficacy of OCT and LAN in obtaining GH and IGF-I levels according to the 2000 Consensus. Furthermore, we wanted to evaluate which treatment modality resulted in the lowest possible IGF-I and GH levels and the highest patient satisfaction.


Condition Intervention Phase
Acromegaly
Drug: Lanreotide Autogel and Octreotide LAR
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction - A Twelve Month Randomized Cross-Over Study in Patients With Acromegaly

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • GH and IGF-I levels after 4, 6, 10, 12 months therapy.

Estimated Enrollment: 12
Study Start Date: September 2002
Estimated Study Completion Date: December 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   22 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All the patients which receive octreotide LAR can be included;
  • New diagnosed patients with clinical and biochemical acromegaly , if medicine therapy is indicated;
  • As long as they do not fit in the exclusion criteria.

Exclusion Criteria:

  • Which had not given their consent after they received standard information about the study;
  • Current malign disease;
  • Somatostatin analogues intolerance;
  • Elevation of lever enzymes;
  • Pregnancy.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00145405

Locations
Denmark
Department of Endocrinology, Odense University Hospital
Odense, Funen, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Marianne Andersen, MD, PhD Odense University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00145405     History of Changes
Other Study ID Numbers: 009
Study First Received: September 2, 2005
Last Updated: September 6, 2006
Health Authority: Denmark: National Board of Health

Keywords provided by Odense University Hospital:
Acromegaly
somatostatin analogues
lanreotide
octreotide
GH
IGF-I
injection site

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
Octreotide
Lanreotide
Angiopeptin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 24, 2014