NCT00088582

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Last Updated

November 7, 2016

Status Verified

November 1, 2016

Enrollment Period

1.6 years

First QC Date

July 30, 2004

Last Update Submit

November 3, 2016

Conditions

Acromegaly

Keywords

AcromegalySOM230Sandostatin

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (1)

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

    Every 3 months

Study Arms (2)

Sandostatin s.c. (Octreotide)

EXPERIMENTAL
Drug: Pasireotide (SOM230), Octreotide (Sandostatin)

Pasireotide (SOM230)

EXPERIMENTAL
Drug: Pasireotide (SOM230), Octreotide (Sandostatin)

Interventions

Pasireotide (SOM230), Octreotide (Sandostatin)DRUG
Pasireotide (SOM230)Sandostatin s.c. (Octreotide)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48108, United States

Location

New York University/VA Medical Center

New York, New York, 10010, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • Petersenn S, Schopohl J, Barkan A, Mohideen P, Colao A, Abs R, Buchelt A, Ho YY, Hu K, Farrall AJ, Melmed S, Biller BM; Pasireotide Acromegaly Study Group. Pasireotide (SOM230) demonstrates efficacy and safety in patients with acromegaly: a randomized, multicenter, phase II trial. J Clin Endocrinol Metab. 2010 Jun;95(6):2781-9. doi: 10.1210/jc.2009-2272. Epub 2010 Apr 21.

    PMID: 20410233RESULT

MeSH Terms

Conditions

Acromegaly

Interventions

pasireotideOctreotide

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2004

First Posted

August 2, 2004

Study Start

March 1, 2004

Primary Completion

October 1, 2005

Last Updated

November 7, 2016

Record last verified: 2016-11

Locations

US(5)