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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00128232
First received: August 8, 2005
Last updated: April 27, 2012
Last verified: April 2012

August 8, 2005
April 27, 2012
December 2002
August 2004   (final data collection date for primary outcome measure)
Mean GH and IGF-I at baseline, week 12, 24 and 48
Not Provided
Complete list of historical versions of study NCT00128232 on ClinicalTrials.gov Archive Site
  • 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
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Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients
Safety and Efficacy of Octreotide LAR in Treatment Naïve Acromegalic Patients

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.

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Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acromegaly
Drug: Octreotide LAR
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
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August 2004   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
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Contact information is only displayed when the study is recruiting subjects
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NCT00128232
CSMS995B2401
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Novartis
Novartis
Not Provided
Principal Investigator: Stephan Petersenn, MD Universität Duisburg-Essen
Novartis
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP