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A Phase 3, Randomized, Active Controlled Study to Evaluate Maintenance of Response, Safety and Patient Reported Outcomes in Acromegaly Patients Treated With Octreotide Capsules vs. Parenteral Somatostatin Receptor Ligands

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Trial Profile

A Phase 3, Randomized, Active Controlled Study to Evaluate Maintenance of Response, Safety and Patient Reported Outcomes in Acromegaly Patients Treated With Octreotide Capsules vs. Parenteral Somatostatin Receptor Ligands

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Aug 2023

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At a glance

  • Drugs Octreotide (Primary) ; Cabergoline; Lanreotide; Octreotide
  • Indications Acromegaly
  • Focus Registrational; Therapeutic Use
  • Acronyms MPOWERED
  • Sponsors Chiasma

Most Recent Events

  • 18 Jun 2023 Results of Predictors of Response to Oral Octreotide Capsules in Patients With Acromegaly , presented at the 105th Annual Meeting of the Endocrine Society
  • 16 Jun 2023 Results assessing long-term efficacy and safety of OOC in patients with acromegaly who previously responded to and tolerated both OOC and injectable octreotide/lanreotide and completed the core phase, published in the Journal of Clinical Endocrinology and Metabolism
  • 05 Dec 2022 According to an Amryt Pharma media release, the European Commission (EC) approval of Mycapssa in the European Union (EU) for the maintenance treatment of acromegaly in patients who have responded to and tolerated treatment with octreotide or lanreotide. The centralised marketing authorisation will be valid in all EU Member States as well as in Iceland, Liechtenstein, and Norway. The EC approval of Mycapssa is supported by efficacy and safety data from three Phase 3 studies including this study.

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