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

NCT01412424 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2017-08-17

Study results available
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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™ treatment in patients with acromegaly.

Conditions

Interventions

DRUG

Octreotide capsules

Octreotide was provided in hard gelatin capsules.

Sponsors & Collaborators

  • Chiasma, Inc.

    lead INDUSTRY

Principal Investigators

  • Shlomo Melmed, MD · Cedars-Sinai Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States
  • Germany
  • Hungary
  • Italy
  • Lithuania
  • Mexico
  • Netherlands
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • Slovenia
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01412424 on ClinicalTrials.gov