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

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

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

Official Title

Safety and Efficacy of Octreotide LAR in Treatment Naïve Acromegalic Patients

Brief Summary

      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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 Tumor volume at baseline, week 24 and 48

Condition

Acromegaly

Intervention

Octreotide LAR

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

100

Start Date

December 2002

Primary Completion Date

August 2004

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 80 Years

Contacts

Stephan Petersenn, MD, ,

Administrative Informations

NCT ID

NCT00128232

Organization ID

CSMS995B2401

Responsible Party

Sponsor

Study Sponsor

Novartis

Study Sponsor

Stephan Petersenn, MD, Principal Investigator, Universität Duisburg-Essen

Verification Date

April 2012