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Trial · Interventional

CompletedPhase 2Registry data

Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

Overview

Status
Completed
Phase
Phase 2
Enrollment
62 participants (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Mar 2004
Primary completion
Oct 2005
Completion
Not stated
First posted
2 Aug 2004 (estimated)
Last update posted
7 Nov 2016 (estimated)
Conditions
Acromegaly

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200420052006
  1. Ph 2

    Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

    NCT00088582

    Mar 2004 to Oct 2005 (primary)

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Pasireotide (SOM230), Octreotide (Sandostatin)Drug

Arms2

  • Experimental

    Sandostatin s.c. (Octreotide)

  • Experimental

    Pasireotide (SOM230)

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · 6 months

Secondary outcomes(1)
  1. Safety and efficacy of multiple doses of Pasireotide s.c. and Sandostatin s.c.

    Time frame · Every 3 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2010

4 results

Pasireotide (SOM230) demonstrates efficacy and safety in patients with acromegaly: a randomized, multicenter, phase II trial.

Petersenn et al. 2010The Journal of clinical endocrinology and metabolismcited by 138

PMID 20410233DOI 10.1210/jc.2009-2272PUB-20410233

Rights unknown4 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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