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OpenTrials
Completed

NCT Number: NCT00225979

Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly

Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. The objective of this study is to assess the safety and efficacy of long-acting repeatable formulation of octreotide and to compare it to the safety and efficacy of surgery in patients with acromegaly who have not had 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

Healthy volunteers accepted: No

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

Inclusion criteria

  • Newly diagnosed or previously untreated acromegalic patients
  • Lack of suppression of GH nadir to <1.0 µg/L, after oral administration of 75 g of glucose (OGTT)
  • 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

Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Octreotide LAR

Drug

Other names: SMS995

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. Quality of life and sleep apnea at baseline, week 12, 24 and 48

  4. Safety and tolerability at any time on treatment

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Sep 26, 2005
Registry last updated
Apr 11, 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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