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Completed

NCT Number: NCT00088582

Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.

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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 2

Primary location

Cedars Sinai Medical Center, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with active acromegaly due to a pituitary adenoma
  • Patients who have been previously treated for acromegaly with certain medications may be required to be without certain medications prior to entering the study

Exclusion criteria

  • Patients with compression of the optic chiasm causing any visual field defect
  • Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression
  • Patients who have received radiotherapy in the 2 years prior to the start of the trial
  • Patients who have congestive heart failure, unstable angina, cardia arrhythmia, or a history of acute myocardial infarction within the three months preceding enrollment
  • Patients with gallstone disease
  • Patients with chronic liver disease
  • Known hypersensitivity to Sandostatin or Sandostatin LAR
  • Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control and highly effective method for birth control
  • History of immunocompromise, including a positive HIV test result
  • Patients who have a history of alcohol or drug abuse in the six-month period prior to the enrollment visit
  • Patients who have participated in any clinical investigation with an investigational drug within 4 weeks prior to dosing

Treatment and study plan

Pasireotide (SOM230), Octreotide (Sandostatin)

Drug

Primary outcomes

  1. Circulating GH- and IGF-1 concentrations measured every 2 weeks

    Time frame: 6 months

Secondary outcomes

  1. Safety and efficacy of multiple doses of Pasireotide s.c. and Sandostatin s.c.

    Time frame: Every 3 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Randomized, Crossover, Open Label Dose Finding Study to Compare the Safety, Efficacy and PK/PD Relationship of Multiple Doses of SOM230 and Sandostatin in Acromegalic Patients

Important dates

Study start
2004
Primary completion
2005
First posted
Aug 2, 2004
Registry last updated
Nov 7, 2016

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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