MedPath

Octreotide

Generic Name
Octreotide
Brand Names
Bynfezia, Mycapssa, Sandostatin
Drug Type
Biotech
CAS Number
83150-76-9
Unique Ingredient Identifier
RWM8CCW8GP
Background

Acromegaly is a disorder caused by excess growth hormone (GH), increasing the growth of body tissues and causing metabolic dysfunction. In most cases, it results from an anterior pituitary growth hormone-releasing tumor. Typically, the feet, hands, and face grow abnormally large; organomegaly and insulin resistance may also occur. Acromegaly is a life-threatening disease requiring life-long management.

Octreotide is a long-acting drug with pharmacologic activities that mimic those of the natural hormone, somatostatin, which inhibits the secretion of growth hormone. Additionally, it is used for the treatment of acromegaly and symptoms arising from various tumors, including carcinoid tumors and vasoactive intestinal tumors (VIPomas). In the past, octreotide has been administered solely by injection. On June 26, 2020, the first approved delayed-release oral somatostatin analog, Mycapssa, received FDA approval for the long term maintenance treatment of acromegaly. This drug was developed by Chiasma Inc.

Indication

Octreotide by injection is used for the treatment of acromegaly and the reduction of flushing and diarrhea symptoms related to carcinoid tumors and/or vasoactive intestinal peptide (VIPoma) tumors. The delayed-release oral formulation is used for the long-term treatment of acromegaly in patients who tolerate and respond adequately to injectable octreotide and lanreotide.

Associated Conditions
Acromegaly, Diarrhea, Metastatic Carcinoid Tumors
Associated Therapies
Long-term maintenance therapy

The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics

Phase 2
Completed
Conditions
Acromegaly
Interventions
First Posted Date
2014-08-15
Last Posted Date
2018-02-15
Lead Sponsor
Aspireo Pharmaceuticals Limited
Target Recruit Count
8
Registration Number
NCT02217800

Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects

Phase 1
Completed
Conditions
Drug Interactions
Interventions
First Posted Date
2014-07-21
Last Posted Date
2016-09-07
Lead Sponsor
Lexicon Pharmaceuticals
Target Recruit Count
24
Registration Number
NCT02195635
Locations
🇺🇸

Lexicon Investigational Site, Daytona Beach, Florida, United States

Hemodynamic Effects of Terlipressin and High Dose Octreotide

Phase 4
Completed
Conditions
Gastric and Esophageal Varices
Interventions
First Posted Date
2014-04-22
Last Posted Date
2016-06-13
Lead Sponsor
Shanghai Zhongshan Hospital
Target Recruit Count
88
Registration Number
NCT02119884
Locations
🇨🇳

180 Fenglin Road, Shanghai, Shanghai, China

Phase II Study With ITF2984 in Acromegalic Patients

Phase 2
Completed
Conditions
Acromegaly
Interventions
Drug: ITF2984 500 mcg
Drug: ITF2984 2000 mcg
Drug: ITF2984 1000 mcg
First Posted Date
2014-04-10
Last Posted Date
2016-06-16
Lead Sponsor
Italfarmaco
Target Recruit Count
48
Registration Number
NCT02111044
Locations
🇫🇷

Hôpital de la TIMONE, Marseille, France

🇨🇿

University Hospital Hradec Kralove, Hradec Kralove, Czech Republic

🇫🇷

Université Hôpital Bicêtre, Le Kremlin-Bicêtre, France

and more 23 locations

Prophylactic Octreotide to Prevent Post Duodenal EMR and Ampullectomy Bleeding

Phase 4
Terminated
Conditions
Adenoma
Interventions
Other: No Octreotide
First Posted Date
2014-01-10
Last Posted Date
2020-07-16
Lead Sponsor
AdventHealth
Target Recruit Count
33
Registration Number
NCT02032784
Locations
🇺🇸

Florida Hospital, Orlando, Florida, United States

Investigation of the Effects of Obesity Surgery on Appetitive Behaviour

Not Applicable
Completed
Conditions
Roux-en-Y Bariatric Surgery
Interventions
Drug: Saline
First Posted Date
2013-12-12
Last Posted Date
2022-05-23
Lead Sponsor
University College Dublin
Target Recruit Count
30
Registration Number
NCT02010385
Locations
🇮🇪

University College Dublin Clinical Research Centre, Dublin, Ireland

Effect of Octreotide on the Colonic Motility in Pediatric Patients

Phase 4
Completed
Conditions
Colonic Motility Index
Constipation
Interventions
First Posted Date
2013-08-07
Last Posted Date
2015-12-21
Lead Sponsor
Indiana University
Target Recruit Count
13
Registration Number
NCT01917773
Locations
🇺🇸

Motility Laboratory, Division of Pediatric Gastroenterology, Hepatology and Nutrition at the James Whitcomb Riley Hospital for Children,, Indianapolis, Indiana, United States

P:II Above-Label Octreotide-LAR With Insufficiently Controlled Carcinoid Syndrome

Phase 2
Terminated
Conditions
Neuroendocrine Carcinoma
Interventions
First Posted Date
2013-06-25
Last Posted Date
2015-01-12
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
2
Registration Number
NCT01886287
Locations
🇺🇸

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

ITF2984 Repeated Doses Study in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Male Volunteers
Interventions
Drug: ITF2984 (500, 1000, 2000 mcg bid for 7 days)
Drug: Placebo
First Posted Date
2013-06-07
Last Posted Date
2013-06-07
Lead Sponsor
Italfarmaco
Target Recruit Count
46
Registration Number
NCT01871844
Locations
🇮🇹

Centro Ricerche Cliniche, Verona, Italy

🇬🇧

Quotient Clinical, Ruddington, Nottingham, United Kingdom

Etiology, Assessment and Treatment of Post-gastric Bypass Severe Hypoglycemia

Not Applicable
Completed
Conditions
Obesity
Surgery
Hypoglycemia
Interventions
Dietary Supplement: Oral Glucose tolerance test (OGGT)
Dietary Supplement: Liquid mixed meal
First Posted Date
2013-05-31
Last Posted Date
2019-10-28
Lead Sponsor
University of Aarhus
Target Recruit Count
33
Registration Number
NCT01865760
Locations
🇩🇰

Department of Endocrinology, Aarhus University Hospital, Aarhus C, Denmark

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