Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ultrasound Guided Octreotide LAR Injection in Acromegaly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00552071
Recruitment Status : Completed
First Posted : November 1, 2007
Results First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
John Carmichael, University of Southern California

Tracking Information
First Submitted Date  ICMJE October 31, 2007
First Posted Date  ICMJE November 1, 2007
Results First Submitted Date  ICMJE February 9, 2018
Results First Posted Date  ICMJE September 11, 2018
Last Update Posted Date September 11, 2018
Study Start Date  ICMJE July 2007
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
Plasma Octreotide Level After Each Treatment Phase [ Time Frame: 3 months ]
Venous sampling was performed at each visit immediately prior to each IM injection. Levels were measured at each visit and mean for the group was calculated after each treatment phase.
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2007)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
Serum IGF-1 Level [ Time Frame: 3 months ]
Venous sampling was performed at each visit immediately prior to each IM injection. Levels were measured at each visit and mean for the group was calculated after each treatment phase.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2007)
IGF-I levels after ultrasound guided octreotide LAR injection compared to non-ultrasound guided injections [ Time Frame: 7 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasound Guided Octreotide LAR Injection in Acromegaly
Official Title  ICMJE Study to Determine Whether Ultrasound Guidance Improves Delivery and Efficacy of Intramuscular Injection of Long-Acting Octreotide in the Treatment of Acromegaly
Brief Summary Approximately half of patients with acromegaly do not respond to treatment with somatostatin receptor ligands such as octreotide LAR. This may be due to inadequate drug delivery if the standard of care regular injection is inaccurately delivered in the intramuscular (IM) compartment. Ultrasound guidance of IM injections may improve accuracy of placement of IM injections and increase drug levels, thereby improving efficacy of octreotide LAR for the treatment of acromegaly. The purpose of this study is to determine whether octreotide LAR drug levels differ if given by ultrasound-guided IM injection or by regular IM injection in patients with acromegaly.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acromegaly
Intervention  ICMJE Drug: Octreotide LAR 30 MG Injection
Stable dose of 30 mg octreotide LAR, or a dose determined by historical dosing, delivered every 28 days for 3 months.
Other Name: Sandostatin LAR
Study Arms  ICMJE
  • Experimental: Ultrasound-guided IM injections of octreotide LAR
    Subjects received octreotide LAR 30 mg injection via ultrasound-guided IM gluteal injection every 28 days for 3 months.
    Intervention: Drug: Octreotide LAR 30 MG Injection
  • Active Comparator: Regular IM injections of octreotide LAR
    Subjects received octreotide LAR 30 mg injection via regular IM gluteal injections every 28 days for 3 months
    Intervention: Drug: Octreotide LAR 30 MG Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2018)
15
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2007)
20
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of active acromegaly based on evidence of a pituitary tumor
  • Historical serum insulin-like growth factor (IGF)-I levels or a lack of suppression of growth hormone (GH) < 1 ng/mL during an oral glucose tolerance test
  • Previous treatment with a stable dose of octreotide LAR for at least 3 months
  • No previous treatment with a stable dose of octreotide LAR for at least 3 months after receiving 3 months of octreotide LAR during a run-in phase prior to any other study-related activity

Exclusion Criteria:

  • Uncontrolled diabetes mellitus
  • Pregnant or breast feeding
  • Current gallstones
  • History of hepatic disease, except patients with < 3 X ULN LFTs indicative of hepatic steatosis
  • Past or current history of cancer, except for basal cell carcinoma or in situ cancer of the cervix
  • History of glucocorticoid therapy within the past 6 months, current treatment with any chemotherapeutic agents or exogenous GH therapy
  • History of investigational drugs administered or received within 30 days of study entry
  • Known hypersensitivity to octreotide LAR
  • Any other concomitant illnesses or therapy that would interfere with evaluation of efficacy or safety or increase the risk for study interruption or discontinuation in the opinion of the investigator or sponsor
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00552071
Other Study ID Numbers  ICMJE 11482
CSMS995BUS60 ( Other Identifier: Other )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party John Carmichael, University of Southern California
Study Sponsor  ICMJE Cedars-Sinai Medical Center
Collaborators  ICMJE Novartis Pharmaceuticals
Investigators  ICMJE
Principal Investigator: John Carmichael, MD University of Southern California
PRS Account Cedars-Sinai Medical Center
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP