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Home » Clinical Trials » Acromegaly

Clinical Trial Details

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating Sandostatin LAR for the treatment of Acromegaly

Research Study Title

Does Ultrasound-Guidance Improve the Delivery and Efficacy of Intramuscular (IM) Injection of Sandostatin LAR in the Treatment of Acromegaly

Purpose

The purpose of this study is to determine the difference in drug levels of Sandostatin after IM injection of Sandostatin LAR without ultrasound guidance (as is the standard of care) compared to drug levels of Sandostatin after IM injection of Sandostatin LAR with ultrasound guidance in subjects with Acromegaly.

To Learn more
Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Cedars-Sinai Medical Center

Duration

41 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • Male and female patients ≥18 years old

  • Patients with active acromegaly due to a pituitary adenoma. Historical data indicating a diagnosis of acromegaly based on circulating IGF-I concentration elevated compared to age and gender matched controls OR GH > 1 mcg/l at 120 Minutes of a two hour OGTT.

  • Currently being treated with Sandostatin LAR and have been treated with a stable dose for 3 months prior to entry into the study.

  • Patients with diabetes may be included, blood glucose and diabetic treatments are to be monitored closely during the trial in these subjects

  • Patients have provided written informed consent

Exclusion Criteria:

  • Uncontrolled diabetes mellitus

  • Patients who are pregnant or lactating

  • Patients who have a known hypersensitivity to Sandostatin acetate or other related drug or compound

  • Patients with current gallstones

  • Patients with a past or current history of cancer, except for basal cell carcinoma or in situ cancer of the cervix

  • Patients with a history of hepatic disease (patients with minimal, i.e., < 3Xs the upper limit of normal for LFTs indicative of hepatic steatosis, MAY participate)

  • Patients who have received glucocorticoid therapy within the past 6 months, or who are currently receiving any chemotherapeutic agents, or exogenous growth hormone therapy

  • Patients who have received other investigational drugs administered or received within 30 days of study entry

  • Patients with unacceptable concomitant diagnoses, or who have received medications and/or therapies (i.e., any concomitant illnesses or therapies that would place the patient at increased risk, or would, in the opinion of the investigator or sponsor, interfere with the evaluation of efficacy or safety) Interruption or discontinuation of treatment

Site Locations (1)

Country State City Zip Facility and Contact
United States California Los Angeles 90048 Cedars-Sinai Medical Center

John D Carmichael, MD
Principal Investigator

Shlomo Melmed, MD
Sub-Investigator

Vivien Bonert, MD
Sub-Investigator

Contact

Billy Gellepis
(310) 423-3395

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT00552071

Date Last Changed: August 18, 2010

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