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
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Condition or disease | Intervention/treatment | Phase |
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Acromegaly | Drug: Octreotide LAR 30 MG Injection | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Study to Determine Whether Ultrasound Guidance Improves Delivery and Efficacy of Intramuscular Injection of Long-Acting Octreotide in the Treatment of Acromegaly |
Study Start Date : | July 2007 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | March 2014 |
Arm | Intervention/treatment |
---|---|
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.
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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 |
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
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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 |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552071
United States, California | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 |
Principal Investigator: | John Carmichael, MD | University of Southern California |
Responsible Party: | John Carmichael, Co Director, Pituitary Program At Keck Medical Center, University of Southern California |
ClinicalTrials.gov Identifier: | NCT00552071 |
Other Study ID Numbers: |
11482 CSMS995BUS60 ( Other Identifier: Other ) |
First Posted: | November 1, 2007 Key Record Dates |
Results First Posted: | September 11, 2018 |
Last Update Posted: | September 11, 2018 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Acromegaly Octreotide LAR Ultrasound guidance |
Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases Octreotide Gastrointestinal Agents Antineoplastic Agents, Hormonal Antineoplastic Agents |