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

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ClinicalTrials.gov Identifier: NCT00145405
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : September 8, 2006
Sponsor:
Information provided by:
Odense University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Acromegaly Drug: Lanreotide Autogel and Octreotide LAR Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : September 2002
Study Completion Date : December 2004





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


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Ages Eligible for Study:   22 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): 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

ClinicalTrials.gov Identifier: NCT00145405     History of Changes
Other Study ID Numbers: 009
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: September 8, 2006
Last Verified: September 2005

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