Ignite Creation Date:
2024-05-06 @ 10:26 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03252353
Status:
UNKNOWN
Last Update Posted:
2020-11-23
First Post:
2017-08-10
Brief Title:
Efficacy and Safety of Octreotide Capsules MYCAPSSA in Acromegaly
Sponsor:
Chiasma Inc
Organization:
Chiasma Inc
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Placebo-controlled Multicenter Study to Evaluate Efficacy and Safety of Octreotide Capsules in Patients Who Demonstrated Biochemical Control on Injectable Somatostatin Receptor Ligands SRL Treatment
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIMAL
Brief Summary:
Octreotide capsule is a novel orally-administered formulation of the commercially-available injectable drug octreotide In a recent phase 3 trial oral octreotide capsules demonstrated maintenance of biochemical response up to 13 months in the majority of patients with acromegaly previously managed with somatostatin analog injections reference below
Detailed Description:
This is a double blind randomized study that assesses the efficacy and safety of octreotide capsules vs placebo Eligible acromegaly patients treated with injectable somatostatin analogs who are biochemically controlled and have prior evidence of active disease will be randomized to receive either octreotide capsules or placebo for up to 36 weeks At the end of this double blind placebo controlled period eligible patients will receive octreotide capsules in an open-labeled extension for at least one year Patients failing to respond per protocol to oral treatment either placebo or octreotide capsules will be rescued with the standard of care and upon meeting the eligibility criteria could also enroll into the long term extension with octreotide capsules
This study received agreement from the FDA under a special protocol assessment
This study received agreement from the FDA under a special protocol assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None