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| ID | Type | Description | Link |
|---|---|---|---|
| CSMS995BUS60 | Other Identifier | Other |
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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound-guided IM injections of octreotide LAR | Experimental | Subjects received octreotide LAR 30 mg injection via ultrasound-guided IM gluteal injection every 28 days for 3 months. |
|
| Regular IM injections of octreotide LAR | Active Comparator | Subjects received octreotide LAR 30 mg injection via regular IM gluteal injections every 28 days for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octreotide LAR 30 MG Injection | Drug | Stable dose of 30 mg octreotide LAR, or a dose determined by historical dosing, delivered every 28 days for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Octreotide Level After Each Treatment Phase | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum IGF-1 Level | 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. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Carmichael, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Regular Injections Followed by Ultrasound-guided Injections |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Octreotide Level After Each Treatment Phase | 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. | 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. | Posted | Mean | Standard Deviation | pg/mL | 3 months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
Small number of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vivian Hwe | Cedars-Sinai Medical Center | 4224-315-4489 | hwev@cshs.org |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| Physician Decision |
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| Pregnancy |
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| Death |
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| Withdrawal by Subject |
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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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
All subjects receiving regular injections during the study. |
|
|
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| Secondary | Serum IGF-1 Level | 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. | 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. | Posted | Mean | Standard Deviation | percentage of upper limit of normal | 3 months |
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|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. | 1 | 11 | 0 | 11 | 1 | 11 |
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| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |