Ultrasound Guided Sandostatin LAR Injection in Acromegaly

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Cedars-Sinai Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00552071
First received: October 31, 2007
Last updated: August 18, 2010
Last verified: August 2010
  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.


Condition Intervention
Acromegaly
Drug: Sandostatin LAR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Ultrasound-Guidance Improve the Delivery and Efficacy of Intramuscular (IM) Injection of Sandostatin LAR in the Treatment of Acromegaly

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Serum drug levels of octreotide after third month of ultrasound guided IM injection of octreotide LAR compared to third month of non-ultrasound guided IM injection of octreotide LAR [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • IGF-I levels after ultrasound guided octreotide LAR injection compared to non-ultrasound guided injections [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: July 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
3 months of ultrasound guided IM injections of octreotide LAR followed by 3 months of non-ultrasound guided injections of octreotide LAR
Drug: Sandostatin LAR
use of consistent monthly dose of medication for duration of 6 months.
Other Name: Ultrasound guided Sandostatin LAR injection
Drug: Sandostatin LAR
All patients receive Sandostatin LAR throughout trial at a fixed dose established at entry into the study.
2
3 months of non-ultrasound guided octreotide LAR IM injections followed by ultrasound guided IM injections of LAR
Drug: Sandostatin LAR
All patients receive Sandostatin LAR throughout trial at a fixed dose established at entry into the study.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00552071

Contacts
Contact: Billy Gellepis (310) 423-3395 gellepisw@cshs.org
Contact: Lori Korsakoff, RN, BSN (310) 423-2411 korsakoffl@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: John D Carmichael, MD         
Sub-Investigator: Shlomo Melmed, MD         
Sub-Investigator: Vivien Bonert, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Novartis Pharmaceuticals
Investigators
Principal Investigator: John D Carmichael, MD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: John Carmichael, MD, Cedars-Sinai Medical Center, Pituitary Center
ClinicalTrials.gov Identifier: NCT00552071     History of Changes
Other Study ID Numbers: 11482, CSMS995BUS60
Study First Received: October 31, 2007
Last Updated: August 18, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Acromegaly
Octreotide LAR
Ultrasound guidance

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014