Current partner codePEPTIDESDE
NCT00088582·Phase 2·INTERVENTIONAL

Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

Status

Completed

Phase

Phase 2

Enrollment

62

Locations

5

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

DRUG

Pasireotide (SOM230), Octreotide (Sandostatin)

Timeline

From registration to results.

  1. First posted

    Aug 2, 2004

  2. Study start

    Mar 2004

  3. Primary completion

    Oct 2005

  4. Study completion

    Not reported

  5. Results posted

    Not reported

  6. Registry updated

    Nov 7, 2016

Outcomes

What the study measures.

Primary outcomes

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

Time frame · 6 months

Secondary outcomes

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

Time frame · Every 3 months

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

5 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Cedars Sinai Medical Center

Los Angeles, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

New York University/VA Medical Center

New York, New York, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Related trials

More studies on Pasireotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.