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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00128232
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : April 30, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: Octreotide LAR Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
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
Study Start Date : December 2002
Actual Primary Completion Date : August 2004

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00128232

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

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Responsible Party: Novartis Identifier: NCT00128232    
Other Study ID Numbers: CSMS995B2401
First Posted: August 9, 2005    Key Record Dates
Last Update Posted: April 30, 2012
Last Verified: April 2012
Keywords provided by Novartis:
newly diagnosed
octreotide LAR
Additional relevant MeSH terms:
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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