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Safety and Efficacy of Octreotide LAR in Treatment Naïve Acromegalic Patients


Phase 3
18 Years
80 Years
Not Enrolling
Both
Acromegaly

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Trial Information

Safety and Efficacy of Octreotide LAR in Treatment Naïve Acromegalic Patients


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Mean GH and IGF-I at baseline, week 12, 24 and 48

Principal Investigator

Stephan Petersenn, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universität Duisburg-Essen

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CSMS995B2401

NCT ID:

NCT00128232

Start Date:

December 2002

Completion Date:

Related Keywords:

  • Acromegaly
  • Acromegaly
  • untreated
  • newly diagnosed
  • octreotide LAR
  • Acromegaly

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