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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT01412424 (opens ClinicalTrials.gov in a new tab)Other idCH-ACM-01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
155 participants (actual)
Sponsor
Chiasma, Inc. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
13 countries

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

Start
Mar 2012
Primary completion
May 2014
Completion
May 2014
First posted
9 Aug 2011 (estimated)
Last update posted
17 Aug 2017
Conditions
Acromegaly

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015
  1. Ph 3

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

    NCT01412424

    Mar 2012 to May 2014

Registry summary

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

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.

Interventions

  • Octreotide capsulesDrug

Arms1

  • Experimental

    Octreotide capsules

    Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Percentage of Responders at the End of the Core Treatment Period

    Time frame · End of the core treatment period (up to 7 months)

    Registry description

    A responder was defined as a participant with a serum insulin-like growth factor-1 (IGF-1) concentration \< 1.3 times the upper limit of normal (adjusted for age and gender) and a growth hormone (GH) concentration \< 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.

  2. Percentage of Responders at the End of the Extension Treatment Period

    Time frame · End of the extension treatment period (up to 13 months)

    Registry description

    A responder was defined as a participant with a serum insulin-like growth factor-1 (IGF-1) concentration \< 1.3 times the upper limit of normal (adjusted for age and gender) and a growth hormone (GH) concentration \< 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.

Secondary outcomes(6)

  1. Percentage of Participants With Specified IGF-1 and GH Concentrations at Baseline and at the End of the Core Treatment Period

    Time frame · Baseline and the end of the core treatment period (up to 7 months)

    Registry description

    Percentage of participants with the following serum insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations at Baseline and at the end of the core treatment period (ECTP): IGF-1 \< 1.3 times the upper limit of normal (ULN) and GH \< 5.0 ng/mL, IGF-1 \< 1.3 times ULN and GH \< 1.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH \< 5.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH \< 2.5 ng/mL, IGF-1 ≤ 1.0 times ULN and GH \< 1.0 ng/mL, IGF-1 \< 1.3 times ULN, IGF-1 ≤ 1.0 times ULN, GH \< 5.0 ng/mL, GH \< 2.5 ng/mL, GH \< 1.0 ng/mL, IGF-1 ≥ 1.3 times ULN and GH \< 2.5 ng/mL, IGF-1 \< 1.3 times ULN and GH ≥ 2.5 ng/mL, and IGF-1 ≥ 1.3 times ULN and GH ≥ 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.

  2. Maintenance of Response During the Fixed Dose Phase of the Core Treatment Period

    Time frame · Beginning of the fixed dose phase of the core treatment period and the end of the core treatment period (up to 7 months)

    Registry description

    Maintenance of response during the fixed dose phase of the core treatment period was defined as the percentage of participants with an insulin-like growth factor-1 (IGF-1) concentration \< 1.3 times the upper limit of normal at the beginning of the fixed dose phase of the core treatment period and at the end of the core treatment period. IGF-1 concentration was determined in serum samples taken at the same visits growth hormone concentration was assessed.

  3. Percentage of Participants With Specified IGF-1 and GH Concentrations at the Beginning and at the End of the Extension Treatment Period

    Time frame · Beginning and the end of the extension treatment period (up to 6 months)

    Registry description

    Percentage of participants with the following serum insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations at the beginning (BETP) and at the end (EETP) of the extension treatment period: IGF-1 \< 1.3 times the upper level of normal (ULN) and GH \< 5.0 ng/mL, IGF-1 \< 1.3 times ULN and GH \< 1.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH \< 5.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH \< 2.5 ng/mL, IGF-1 ≤ 1.0 times ULN and GH \< 1.0 ng/mL, IGF-1 \< 1.3 times ULN, IGF-1 ≤ 1.0 times ULN, GH \< 5.0 ng/mL, GH \< 2.5 ng/mL, GH \< 1.0 ng/mL, IGF-1 ≥ 1.3 times ULN and GH \< 2.5 ng/mL, IGF-1 \< 1.3 times ULN and GH ≥ 2.5 ng/mL, and IGF-1 ≥ 1.3 times ULN and GH ≥ 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.

  4. Maintenance of Response During the Extension Treatment Period

    Time frame · Beginning of the extension treatment period and the end of the extension treatment period (up to 13 months)

    Registry description

    Maintenance of an insulin-like growth factor-1 (IGF-1) response during the extension treatment period was defined as the percentage of participants with an IGF-1 concentration \< 1.3 times the upper limit of normal at the beginning of the extension treatment period and at the end of the extension treatment period. IGF-1 concentration was determined in serum samples taken at the same visits growth hormone concentration was assessed.

  5. Percentage of Participants With Improved or Maintained Acromegaly Symptoms at the End of the Extension Treatment Period

    Time frame · Baseline and the end of the extension treatment period (up to 13 months)

    Registry description

    The severity (absent, mild, moderate, severe) of the 5 acromegaly symptoms headache, perspiration, asthenia, swelling of extremities, and joint pain was assessed at Baseline and at the end of the extension treatment period. The percentage of participants with improved or maintained (no change) acromegaly symptoms from Baseline at the end of the extension treatment period is reported.

  6. Percentage of Participants With ≥ 1, 2, or 3 Acromegaly Symptoms at Baseline and at the End of the Extension Treatment Period

    Time frame · Baseline and the end of the extension treatment period (up to 13 months)

    Registry description

    Reported is the percentage of participants who had ≥ 1, 2, or 3 of the 5 symptoms of acromegaly (headaches, perspiration, asthenia, swelling of extremities, or joint pain) of any severity (mild, moderate, or severe). This was a post hoc analysis.

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 outcomeNumber· End of the core treatment period (up to 7 months)

Percentage of Responders at the End of the Core Treatment Period

GroupValue (Percentage of responders)
Octreotide 40 mg86.9
Octreotide 60 mg66.7
Octreotide 80 mg40.4
Octreotide 40, 60, or 80 mg - All Participants64.9
Primary outcomeNumber· End of the extension treatment period (up to 13 months)

Percentage of Responders at the End of the Extension Treatment Period

GroupValue (Percentage of responders)
Octreotide Capsules78.4
Secondary and other outcome results(6)
Secondary outcomeNumber· Baseline and the end of the core treatment period (up to 7 months)

Percentage of Participants With Specified IGF-1 and GH Concentrations at Baseline and at the End of the Core Treatment Period

GroupValue (Percentage of participants)
Octreotide Capsules91.4
Secondary outcomeNumber· Beginning of the fixed dose phase of the core treatment period and the end of the core treatment period (up to 7 months)

Maintenance of Response During the Fixed Dose Phase of the Core Treatment Period

GroupValue (Percentage of participants)
Octreotide Capsules82.7
Secondary outcomeNumber· Beginning and the end of the extension treatment period (up to 6 months)

Percentage of Participants With Specified IGF-1 and GH Concentrations at the Beginning and at the End of the Extension Treatment Period

GroupValue (Percentage of participants)
Octreotide Capsules84.1
Secondary outcomeNumber· Beginning of the extension treatment period and the end of the extension treatment period (up to 13 months)

Maintenance of Response During the Extension Treatment Period

GroupValue (Percentage of participants)
Octreotide Capsules87.8
Secondary outcomeNumber· Baseline and the end of the extension treatment period (up to 13 months)

Percentage of Participants With Improved or Maintained Acromegaly Symptoms at the End of the Extension Treatment Period

GroupValue (Percentage of participants)
Octreotide Capsules27
Secondary outcomeNumber· Baseline and the end of the extension treatment period (up to 13 months)

Percentage of Participants With ≥ 1, 2, or 3 Acromegaly Symptoms at Baseline and at the End of the Extension Treatment Period

GroupValue (Percentage of participants)
Octreotide Capsules78

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Octreotide 40 mgParticipants received octreotide 20 mg orally twice a day for up to 13 months.1 / 1559 / 155103 / 155
Octreotide 60 mgParticipants received octreotide 40 mg in the morning and octreotide 20 mg in the evening orally for up to 13 months.0 / 917 / 9151 / 91
Octreotide 80 mgParticipants received octreotide 40 mg in the morning and octreotide 40 mg in the evening orally for up to 13 months.1 / 588 / 5831 / 58

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

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

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

1 study 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

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Criteria: * 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.

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