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Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: August 8, 2005
Last updated: April 27, 2012
Last verified: April 2012
Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. Octreotide LAR is approved for treatment of acromegaly after surgery if the disease is not controlled. This study was aimed to test the safety and efficacy of octreotide LAR in acromegalic patients who did not have any previous treatment for acromegaly.

Condition Intervention Phase
Acromegaly Drug: Octreotide LAR Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Octreotide LAR in Treatment Naïve Acromegalic Patients

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Mean GH and IGF-I at baseline, week 12, 24 and 48

Secondary Outcome Measures:
  • Tumor volume at baseline, week 24 and 48
  • Signs and symptoms of acromegaly at baseline, week 12, 24 and 48
  • Safety and tolerability at any time on treatment

Estimated Enrollment: 100
Study Start Date: December 2002
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Newly diagnosed or previously untreated acromegalic patients
  • Lack of suppression of growth hormone (GH) nadir to <1.0 µg/L, after oral administration of 75g of glucose (oral glucose tolerance test [OGTT])
  • Insulin-like growth factor-I (IGF-I) levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender)

Exclusion Criteria:

  • Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass
  • No evidence of pituitary adenoma on magnetic resonance imaging (MRI)
  • Symptomatic cholelithiasis
  Contacts and Locations
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Please refer to this study by its identifier: NCT00128232

Sponsors and Collaborators
Principal Investigator: Stephan Petersenn, MD Universität Duisburg-Essen
  More Information

Responsible Party: Novartis Identifier: NCT00128232     History of Changes
Other Study ID Numbers: CSMS995B2401
Study First Received: August 8, 2005
Last Updated: April 27, 2012

Keywords provided by Novartis:
newly diagnosed
octreotide LAR

Additional relevant MeSH terms:
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on September 21, 2017