CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Pasireotidedrug
Likely dose
Pasireotide 200, 400, or 600 μg twice daily (or Sandostatin 100 μg three times daily)AI-extracted
Key inclusion· 2
  • ✓Completed all four treatment regimens in core study CSOM230B2201 and achieved biochemical control of GH and IGF-1 levels after at least one month of pasireotide at any of the three doses
  • ✓No unacceptable adverse events or tolerability issues during the core study
Key exclusion· 3
  • ✕Compression of the optic chiasm causing visual field defect during the core study
  • ✕Required surgical intervention for relief of tumor compression signs or symptoms during the core study
  • ✕Experienced congestive heart failure, unstable angina, sustained ventricular tachycardia, ventricular fibrillation, or acute myocardial infarction during the core study

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00171730
NCT00171730Phase 2Completed
CompareCT.gov

Extension to a Multi-Center, Randomized, Crossover, Open Label, Dose Finding Study to Compare the Safety, Efficacy, and Pharmacokinetics/Pharmacodynamics (PK/PD) Relationship of Multiple Doses of Pasireotide (SOM230) (200, 400, and 600 μg Bid) and Doses of Open Label Sandostatin® (SMS) (100 μg Tid) in Acromegalic Patients

Novartis Pharmaceuticals·interventional·Posted Sep 15, 2005·Updated Sep 5, 2021

In Brief

A Phase 2 clinical trial evaluating Pasireotide for Acromegaly. Completed, enrolled 30 participants across 10 sites in 7 countries.

Detailed Summary

Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth hormone (GH), generally caused by a GH-secreting pituitary adenoma. The study assessed the long-term safety and efficacy of pasireotide in participants with acromegaly.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcromegaly
CountriesAustralia, Belgium, France, Germany, Italy, Switzerland, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartAug 24, 2004
Primary CompletionDec 6, 2013
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 20.8 years ago

Interventions

Pasireotidedrug