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Trial · Interventional

Status unknownPhase 3Results postedRegistry data

Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

Short name OPTIMAL

NCTNCT03252353 (opens ClinicalTrials.gov in a new tab)Other idOOC-ACM-303
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 3
Enrollment
56 participants (actual)
Sponsor
Chiasma, Inc. · Industry
Design
Randomized · Triple masking
Countries
17 countries

United States, Australia, Bulgaria, Canada, Denmark, Germany, Hungary, Israel, Italy, Latvia, Netherlands, New Zealand, Poland, Slovenia, Sweden, Turkey (Türkiye), United Kingdom

Start
1 Sept 2017
Primary completion
13 Jun 2019
Completion
May 2022 (estimated)
First posted
17 Aug 2017
Last update posted
23 Nov 2020
Conditions
Acromegaly

Timeline

1 trial · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020202120222023
  1. Ph 3

    OPTIMAL

    NCT03252353

    1 Sept 2017 to est. May 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • octreotide capsulesDrug
  • Matching placeboDrug

Arms2

  • Active comparator

    Octreotide capsules

    Octreotide capsules

  • Placebo comparator

    Matching Placebo

    Matching placebo capsules

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period.

    Time frame · Week 36

    Registry description

    Maintenance of response was defined by using the average IGF-1 level of the last 2 available assessments in the DPC period. If the average IGF-1 is ≤ 1×ULN, a patient was classified as a responder (i.e., maintained their biochemical response). If the average IGF-1 is \> 1×ULN, a patient was classified as a non-responder. Patients who discontinue study medication during the DPC period for any reason was classified as non-responders for the primary analysis, regardless of their IGF-1 values.

Secondary outcomes(2)

  1. Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period

    Time frame · Week 36

    Registry description

    Maintenance of GH response was defined as having mean Growth Hormone (5 measurements 30 minutes apart) \< 2.5 ng/mL at the end of the double blind placebo controlled period, out of those who were responders on Somatostatin Receptor Ligands (SRLs) injections at Screening.

  2. Number of Patients Who Begin Rescue Treatment

    Time frame · Week 36

    Registry description

    Number of Patients who Began Rescue Treatment Prior to and Including Week 36

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Week 36

Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period.

GroupValue (Participants)
Octreotide Capsules16
Matching Placebo5
Secondary and other outcome results(2)
Secondary outcomeCount of participants· Week 36

Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period

GroupValue (Participants)
Octreotide Capsules21
Placebo7
Secondary outcomeCount of participants· Week 36

Number of Patients Who Begin Rescue Treatment

GroupValue (Participants)
Octreotide Capsules7
Placebo19

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Octreotide CapsulesOctreotide capsules octreotide capsules: octreotide capsules 40mg/day, 60mg/day, 80 mg/day (individual dose titration)0 / 282 / 2828 / 28
Matching PlaceboMatching placebo capsules Matching placebo: Matching placebo capsules0 / 281 / 2827 / 28

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2020

7 results

Maintenance of Acromegaly Control in Patients Switching From Injectable Somatostatin Receptor Ligands to Oral Octreotide.

Samson et al. 2020The Journal of clinical endocrinology and metabolismcited by 80

PMID 32882036PMC7470473DOI 10.1210/clinem/dgaa526PUB-32882036

CC BY7 results
Download PDFSee results (7)

Indexing hint: Clinical trial · 2015

Corrected7 results

Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial.

Melmed et al. 2015The Journal of clinical endocrinology and metabolismcited by 135

PMID 25664604DOI 10.1210/jc.2014-4113PUB-25664604

Full text at the publisher7 results
Publisher pageRead the noticeSee results (7)

More studies

2 studies on this page

Indexing hint: Randomized controlled trial · 2021

Corrected

Oral octreotide capsules for the treatment of acromegaly: comparison of 2 phase 3 trial results.

Labadzhyan et al. 2021Pituitarycited by 16

PMID 34173129PMC8550586DOI 10.1007/s11102-021-01163-2PUB-34173129

CC BY
Download PDFRead the notice

Indexing hint: Randomized controlled trial · 2012

Oral octreotide absorption in human subjects: comparable pharmacokinetics to parenteral octreotide and effective growth hormone suppression.

Tuvia et al. 2012The Journal of clinical endocrinology and metabolismcited by 121

PMID 22539587DOI 10.1210/jc.2012-1179PUB-22539587

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Documented evidence of active acromegaly * Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months with a stable dose for at least the last three months of therapy * Biochemically controlled Exclusion Criteria: * Patients taking injections of long-acting Somatostatin Receptor Ligands (SRLs) not as indicated in the label * Pituitary surgery within six months * Conventional or stereotactic pituitary radiotherapy any time in the past * Patients who previously participated in CH-ACM-01 or OOC-ACM-302 * Any clinically significant uncontrolled concomitant disease * Symptomatic cholelithiasis * Pegvisomant, within 24 weeks * Dopamine agonists, within 12 weeks * Pasireotide, within 24 weeks

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