Ultrasound Guided Octreotide LAR Injection in Acromegaly

• 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: Cedars-Sinai Medical Center
• Collaborator: Novartis Pharmaceuticals
• Information provided by (Responsible Party): John Carmichael, University of Southern California

Tracking Information

• First Submitted Date: October 31, 2007
• First Posted Date: November 1, 2007
• Results First Submitted Date: February 9, 2018
• Results First Posted Date: September 11, 2018
• Last Update Posted Date: September 11, 2018
• Study Start Date: July 2007
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: Ultrasound Guided Octreotide LAR Injection in Acromegaly
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Acromegaly

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 13, 2018): 15
• Original Estimated Enrollment (submitted: October 31, 2007): 20
• Actual Study Completion Date: March 2014
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00552071
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: John Carmichael, University of Southern California
• Study Sponsor: Cedars-Sinai Medical Center
• Collaborators: Novartis Pharmaceuticals

Investigators

• Principal Investigator: John Carmichael, MD; University of Southern California

• PRS Account: Cedars-Sinai Medical Center
• Verification Date: August 2018