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OpenTrials
Completed

NCT Number: NCT00128232

Safety and Efficacy of Octreotide Long Acting Release (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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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Octreotide LAR

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Safety and Efficacy of Octreotide LAR in Treatment Naïve Acromegalic Patients

Important dates

Study start
2002
Primary completion
2004
First posted
Aug 9, 2005
Registry last updated
Apr 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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