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Ultrasound Guided Octreotide LAR Injection in Acromegaly

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acromegaly
Intervention Drug: Octreotide LAR 30 MG Injection
Enrollment 15
Recruitment Details This study recruited subjects with active acromegaly. Equal numbers of men and women were to be recruited, but the recruitment plan was adjusted during the course of the trial to account for the high number of women withdrawn from the study. 12 women and 9 men were recruited; 8 men and 7 women completed the study and were included in the analysis.
Pre-assignment Details Subjects who had not received 3 monthly injections of a stable dose of octreotide LAR prior to enrollment were given 3 monthly injections of octreotide LAR at a stable dose of 30 mg every 28 days or at a dose determined by historical dosing. Nine of the 15 subjects participated in this run-in period.
Arm/Group Title Ultrasound-guided Injections Followed by Regular Injections Regular Injections Followed by Ultrasound-guided Injections
Hide Arm/Group Description Subjects received octreotide LAR via ultrasound-guided IM gluteal injections every 28 days for 3 months followed by regular IM gluteal injections every 28 days for 3 months. Subjects received octreotide LAR via regular IM gluteal injections every 28 days for 3 months followed by ultrasound-guided IM gluteal injections every 28 days for 3 months.
Period Title: Overall Study
Started 10 11
Completed 6 9
Not Completed 4 2
Reason Not Completed
Adverse Event             1             0
Lack of Efficacy             1             0
Physician Decision             1             0
Pregnancy             1             0
Death             0             1
Withdrawal by Subject             0             1
Arm/Group Title Ultrasound-guided Injections Followed by Regular Injections Regular Injections Followed by Ultrasound-guided Injections Total
Hide Arm/Group Description Subjects received octreotide LAR via ultrasound-guided IM gluteal injections every 28 days for 3 months followed by regular IM gluteal injections every 28 days for 3 months. Subjects received octreotide LAR via regular IM gluteal injections every 28 days for 3 months followed by ultrasound-guided IM gluteal injections every 28 days for 3 months. Total of all reporting groups
Overall Number of Baseline Participants 6 9 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 9 participants 15 participants
56  (14) 53  (16) 53  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 9 participants 15 participants
Female
2
  33.3%
5
  55.6%
7
  46.7%
Male
4
  66.7%
4
  44.4%
8
  53.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 9 participants 15 participants
6 9 15
1.Primary Outcome
Title Plasma Octreotide Level After Each Treatment Phase
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects were regrouped for analysis by treatment. Octreotide levels after 3 monthly octreotide LAR injections with ultrasound guidance were compared to octreotide levels obtained after 3 monthly octreotide LAR injection without ultrasound guidance.
Arm/Group Title Ultrasound-guided Injections of Octreotide LAR Regular Injections of Octreotide LAR
Hide Arm/Group Description:
All subjects receiving ultrasound-guided injections during the study.
All subjects receiving regular injections during the study.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: pg/mL
885  (702) 1167  (1126)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ultrasound-guided Injections of Octreotide LAR, Regular Injections of Octreotide LAR
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments A two-sided p value of <0.05 was considered significant.
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Serum IGF-1 Level
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects were regrouped for analysis by treatment. Serum IGF-I levels after 3 monthly octreotide LAR injections with ultrasound guidance were compared to Serum IGF-I levels obtained after 3 monthly octreotide LAR injection without ultrasound guidance.
Arm/Group Title Ultrasound-guided Injections of Octreotide LAR Regular Injections of Octreotide LAR
Hide Arm/Group Description:
All subjects who recieved ultrasound-guided injections during the study.
All subjects who received regular injections during the study.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: percentage of upper limit of normal
132  (92) 124  (83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ultrasound-guided Injections of Octreotide LAR, Regular Injections of Octreotide LAR
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments A two-sided p value of <0.05 was considered significant.
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description Arms/Groups cannot be provided for each intervention separately, as it was not reported which intervention was being administered at the time the adverse events occurred. Arm 1 refers to the group who received ultrasound-guided injections first and then crossed over to regular injections, and Arm 2 refers to the group who received regular injections and crossed over to ultrasound-guided injections.
 
Arm/Group Title Ultrasound-guided Injections Followed by Regular Injections Regular Injections Followed by Ultrasound-guided Injections
Hide Arm/Group Description Subjects received octreotide LAR via ultrasound-guided IM gluteal injections every 28 days for 3 months followed by regular IM gluteal injections every 28 days for 3 months. Subjects received octreotide LAR via regular IM gluteal injections every 28 days for 3 months followed by ultrasound-guided IM gluteal injections every 28 days for 3 months.
All-Cause Mortality
Ultrasound-guided Injections Followed by Regular Injections Regular Injections Followed by Ultrasound-guided Injections
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      1/11 (9.09%)    
Hide Serious Adverse Events
Ultrasound-guided Injections Followed by Regular Injections Regular Injections Followed by Ultrasound-guided Injections
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/11 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ultrasound-guided Injections Followed by Regular Injections Regular Injections Followed by Ultrasound-guided Injections
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      1/11 (9.09%)    
Cardiac disorders     
Chest pain *  0/10 (0.00%)  0 1/11 (9.09%)  1
*
Indicates events were collected by non-systematic assessment
Small number of subjects analyzed
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vivian Hwe
Organization: Cedars-Sinai Medical Center
Phone: 4224-315-4489
EMail: hwev@cshs.org
Layout table for additonal information
Responsible Party: John Carmichael, University of Southern California
ClinicalTrials.gov Identifier: NCT00552071    
Other Study ID Numbers: 11482
CSMS995BUS60 ( Other Identifier: Other )
First Submitted: October 31, 2007
First Posted: November 1, 2007
Results First Submitted: February 9, 2018
Results First Posted: September 11, 2018
Last Update Posted: September 11, 2018