Los Angeles, California 90048


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.


Study summary:

IM intragluteal injections have been reported to be inaccurate in their placement in the intramuscular compartment when performed as dictated by the current standard of care. This inaccuracy of placement may have an effect on the efficacy of drugs delivered by the IM route. Furthermore, the inaccuracy of IM injections was found to be directly related to BMI and was found to be more inaccurate in female subjects. Ultrasound guidance of IM injections will improve the accuracy of placement of IM injections and may improve drug levels and efficacy of Sandostatin LAR in the treatment of Acromegaly.


Criteria:

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


NCT ID:

NCT00552071


Primary Contact:

Principal Investigator
John D Carmichael, MD
Cedars-Sinai Medical Center

Billy Gellepis
Phone: (310) 423-3395
Email: gellepisw@cshs.org


Backup Contact:

Email: korsakoffl@cshs.org
Lori Korsakoff, RN, BSN
Phone: (310) 423-2411


Location Contact:

Los Angeles, California 90048
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 22, 2018

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