Efficacy and Safety of Octreotide (MYCAPSSA™ [Formerly Octreolin™]) for Acromegaly

Completed · Phase 3

Conditions studied: Acromegaly

In brief

MYCAPSSA™ (formerly Octreolin™) is a proprietary oral form of the approved injectable medical product octreotide used to treat acromegaly. This study will evaluate the efficacy and safety of MYCAPSSA™ treatment in patients with acromegaly.

Key facts

Study ID

NCT01412424

Run by

Chiasma, Inc.

People needed

155

Starts

2012-03-01

Expected to finish

2014-05-01

Last updated by the study team

2017-08-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult subjects, aged 18 to 75 years old, inclusive.
• Subjects with acromegaly defined as documented evidence of growth hormone-secreting pituitary tumor that is abnormally responsive to glucose, or documented elevated insulin-like growth factor-1 (IGF-1), who are currently receiving a stable dose of a somatostatin analog for at least the previous 3 months.
• A serum IGF-1 level < 1.3 x the upper limit of normal (ULN) and a serum growth hormone (GH) level < 2.5 ng/mL.
• Subjects able and willing to comply with the requirements of the protocol.
• Subjects able to swallow capsules.
• Subjects able to understand and sign written informed consent to participate in the study.

You may not qualify if…

• Receiving regular injections of a somatostatin analog less frequently than once a month, ie, longer than every 4 weeks.
• Symptomatic cholelithiasis.
• Received pituitary radiotherapy within ten years prior to screening.
• Undergone pituitary surgery within the prior 6 months.
• Any condition that may jeopardize study participation.
• Clinically significant gastrointestinal (GI), renal, or hepatic disease as determined by the Investigator.
• Conditions (eg, bariatric surgery) significantly affecting gastric acidity or emptying.
• Current use (within 1 month) of proton pump inhibitors (PPIs) and current chronic use of H2-antagonists.
• Female patients who are pregnant or lactating.
• Current or recent (< 3 months) therapy with pegvisomant.
• Current or recent (< 2 months) therapy with cabergoline.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Campus Charité Mitte — Berlin, Germany
• ENDOC Center for Endocrine Tumors — Hamburg, Germany
• Medizinische Klinik Innenstadt — Munich, Germany
• Max Planck Institute of Psychiatry — Munich, Germany
• Praxis for Endocrimology and Diabetology in Oldenburg — Oldenburg, Germany
• Military Hospital, State Health Center 2nd Department of Internal Medicine — Budapest, Hungary
• Semmelweiss University — Budapest, Hungary
• University of Pecs — Pécs, Hungary
• University of Szeged — Szeged, Hungary
• Servizio di Endocrinologia A.O. Spedali Civili di Brescia — Brescia, Italy
• Dipartimento Clinico Sperimentale di Medicina e Farmacologia — Messina, Italy
• Ospedale Molinette — Torino, Italy
• Hospital of Lithuanian University of Health Sciences Kauno Klinikos — Kaunas, Lithuania
• Vilnius University Hospital Santariskiu Clinics Center of Endocrinology — Vilnius, Lithuania
• Unidad de Investigacion Clinica Cardiometabolica de Occidente — Guadalajara Jalisco, Mexico
• Instituto Nacional de Neurologia y Neurocirugía - National Institute of Neurology and Neurosurgery — Mexico City, Mexico
• Centro Medico ABC — Mexico City, Mexico
• Leiden University Medical Centre — Leiden, Netherlands
• Erasmus University Medical Center — Rotterdam, Netherlands
• Autonomous Public Clinical Hospital No. 5 — Katowice, Poland
• Department of Endocrinology - Jagiellonian University, Krakow — Krakow, Poland
• Clinical Hospital of Medical University in Poznan — Poznan, Poland
• Bielanski Hospital — Warsaw, Poland
• Wroclaw Medical University — Wroclaw, Poland

Full record on ClinicalTrials.gov

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