Trial Outcomes & Findings for Ultrasound Guided Octreotide LAR Injection in Acromegaly (NCT NCT00552071)
NCT ID: NCT00552071
Last Updated: 2018-09-11
Results Overview
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.
COMPLETED
PHASE4
15 participants
3 months
2018-09-11
Participant Flow
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recruited, but the recruitment plan was adjusted during the course of the trial to account for the high number of women withdrawn from the study. 12 women and 9 men were recruited; 8 men and 7 women completed the study and were included in the analysis.
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.
Participant milestones
| Measure |
Ultrasound-guided Injections Followed by Regular Injections
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.
|
Regular Injections Followed by Ultrasound-guided Injections
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Ultrasound-guided Injections Followed by Regular Injections
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.
|
Regular Injections Followed by Ultrasound-guided Injections
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ultrasound-guided Injections Followed by Regular Injections
n=6 Participants
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.
|
Regular Injections Followed by Ultrasound-guided Injections
n=9 Participants
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
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 14 • n=6 Participants
|
53 years
STANDARD_DEVIATION 16 • n=9 Participants
|
53 years
STANDARD_DEVIATION 15 • n=15 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=6 Participants
|
5 Participants
n=9 Participants
|
7 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
8 Participants
n=15 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 participants
n=6 Participants
|
9 participants
n=9 Participants
|
15 participants
n=15 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Ultrasound-guided Injections of Octreotide LAR
n=15 Participants
All subjects receiving ultrasound-guided injections during the study.
|
Regular Injections of Octreotide LAR
n=15 Participants
All subjects receiving regular injections during the study.
|
|---|---|---|
|
Plasma Octreotide Level After Each Treatment Phase
|
885 pg/mL
Standard Deviation 702
|
1167 pg/mL
Standard Deviation 1126
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Ultrasound-guided Injections of Octreotide LAR
n=15 Participants
All subjects receiving ultrasound-guided injections during the study.
|
Regular Injections of Octreotide LAR
n=15 Participants
All subjects receiving regular injections during the study.
|
|---|---|---|
|
Serum IGF-1 Level
|
132 percentage of upper limit of normal
Standard Deviation 92
|
124 percentage of upper limit of normal
Standard Deviation 83
|
Adverse Events
Ultrasound-guided Injections Followed by Regular Injections
Regular Injections Followed by Ultrasound-guided Injections
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ultrasound-guided Injections Followed by Regular Injections
n=10 participants at risk
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.
|
Regular Injections Followed by Ultrasound-guided Injections
n=11 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Chest pain
|
0.00%
0/10 • 6 months
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.
|
9.1%
1/11 • Number of events 1 • 6 months
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place