Status:
COMPLETED
Efficacy and Safety of Octreotide (MYCAPSSA™ [Formerly Octreolin™]) for Acromegaly
Lead Sponsor:
Chiasma, Inc.
Conditions:
Acromegaly
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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™...
Detailed Description
The study consisted of 2 periods, a Core Treatment Period of up to 7 months and an optional Extension Treatment Period of up to 6 months, for a total study duration of up to 13 months. The Core Treatm...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT01412424
Start Date
March 1 2012
End Date
May 1 2014
Last Update
August 17 2017
Active Locations (36)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Campus Charité Mitte
Berlin, Germany
3
ENDOC Center for Endocrine Tumors
Hamburg, Germany, 20357
4
Medizinische Klinik Innenstadt
Munich, Germany, 80336