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Study · Non-randomized trial · n = 151 · 2015

7 resultsCorrected

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

Melmed S, Popovic V, Bidlingmaier M, Mercado M, van der Lely AJ, Biermasz N, Bolanowski M, Coculescu M, Schopohl J, Racz K, Glaser B, Goth M and 13 more

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Greenman Y, Trainer P, Mezosi E, Shimon I, Giustina A, Korbonits M, Bronstein MD, Kleinberg D, Teichman S, Gliko-Kabir I, Mamluk R, Haviv A, Strasburger C

The Journal of clinical endocrinology and metabolism9 Feb 2015Cited by 135 (Europe PMC)

PMID25664604 (opens in a new tab)DOI10.1210/jc.2014-4113 (opens in a new tab)PepBankPUB-25664604
Publisher pagePubMedAsk about this study
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CorrectedReported by Europe PMC

The publisher issued a correction. Read the notice to see what changed. PepBank shows the study as the source lists it today.

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In evaluable patients with acromegaly, 65% maintained combined IGF-1 and GH control after switching to oral octreotide through core treatment.

    In plain wordsIn patients with acromegaly, 65% maintained combined hormone control after switching to oral octreotide through core treatment.

    Peptide
    Octreotide
    Outcome
    Not applicableBiochemical control at core treatment end
    Study

    n = 151

    Analysis
    Primary
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    40 mg/d, escalated to 60 and then up to 80 mg/d · oral · 7 monthsAs given in this study (human).

    Measurements

    Response
    65%
    core treatment end
    IGF-1 threshold
    < 1.3 × ULN
    response definition
    GH threshold
    < 2.5 ng/mL
    response definition

    Source sentences

    Summary
    Of 151 evaluable subjects initiating OOCs, 65% maintained response and achieved the primary endpoint of IGF-1 <1.3 × ULN and mean integrated GH <2.5 ng/mL at the end of the core treatment period and 62% at the end of treatment (up to 13 mo).
    4 context sentences
    Summary · context
    A novel oral octreotide formulation was tested for efficacy and safety in a phase III, multicenter, open-label, dose-titration, baseline-controlled study in patients with acromegaly.
    Summary · context
    We enrolled 155 complete or partially controlled patients (IGF-1 <1.3 × upper limit of normal [ULN], and 2-h integrated GH <2.5 ng/mL) receiving injectable somatostatin receptor ligand (SRL) for ≥ 3 months.
    Summary · context
    Subjects were switched to 40 mg/d oral octreotide capsules (OOCs), and the dose escalated to 60 and then up to 80 mg/d to control IGF-1.
    Summary · context
    Subsequent fixed doses were maintained for a 7-month core treatment, followed by a voluntary 6-month extension.
  2. 02HumanNon-randomized trialEfficacy outcome

    In evaluable patients with acromegaly, 62% maintained combined IGF-1 and GH control on oral octreotide at treatment end, up to 13 months.

    In plain wordsIn patients with acromegaly, 62% maintained combined hormone control on oral octreotide at treatment end, up to 13 months.

    Peptide
    Octreotide
    Outcome
    Not applicableBiochemical control at treatment end
    Study

    n = 151

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    40 mg/d, escalated to 60 and then up to 80 mg/d · oral · up to 13 monthsAs given in this study (human).

    Measurements

    Response
    62%
    treatment end

    Source sentences

    Summary
    Of 151 evaluable subjects initiating OOCs, 65% maintained response and achieved the primary endpoint of IGF-1 <1.3 × ULN and mean integrated GH <2.5 ng/mL at the end of the core treatment period and 62% at the end of treatment (up to 13 mo).
    4 context sentences
    Summary · context
    A novel oral octreotide formulation was tested for efficacy and safety in a phase III, multicenter, open-label, dose-titration, baseline-controlled study in patients with acromegaly.
    Summary · context
    We enrolled 155 complete or partially controlled patients (IGF-1 <1.3 × upper limit of normal [ULN], and 2-h integrated GH <2.5 ng/mL) receiving injectable somatostatin receptor ligand (SRL) for ≥ 3 months.
    Summary · context
    Subjects were switched to 40 mg/d oral octreotide capsules (OOCs), and the dose escalated to 60 and then up to 80 mg/d to control IGF-1.
    Summary · context
    Subsequent fixed doses were maintained for a 7-month core treatment, followed by a voluntary 6-month extension.
  3. 03HumanNon-randomized trialEfficacy outcome

    In acromegaly patients initially controlled on oral octreotide, 85% maintained response up to 13 months.

    In plain wordsIn acromegaly patients initially controlled on oral octreotide, 85% maintained response up to 13 months.

    Peptide
    Octreotide
    Outcome
    Not applicableDurability among initially controlled subjects
    Study

    n: not reported in source

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    40 mg/d, escalated to 60 and then up to 80 mg/d · oral · up to 13 monthsAs given in this study (human).

    Measurements

    Maintained response
    85%
    initially controlled subjects

    Source sentences

    Summary
    The effect was durable, and 85 % of subjects initially controlled on OOCs maintained this response up to 13 months.
    4 context sentences
    Summary · context
    A novel oral octreotide formulation was tested for efficacy and safety in a phase III, multicenter, open-label, dose-titration, baseline-controlled study in patients with acromegaly.
    Summary · context
    We enrolled 155 complete or partially controlled patients (IGF-1 <1.3 × upper limit of normal [ULN], and 2-h integrated GH <2.5 ng/mL) receiving injectable somatostatin receptor ligand (SRL) for ≥ 3 months.
    Summary · context
    Subjects were switched to 40 mg/d oral octreotide capsules (OOCs), and the dose escalated to 60 and then up to 80 mg/d to control IGF-1.
    Summary · context
    Subsequent fixed doses were maintained for a 7-month core treatment, followed by a voluntary 6-month extension.
  4. 04HumanNon-randomized trialEfficacy outcome

    In acromegaly patients controlled on oral octreotide, GH levels decreased compared with baseline.

    In plain wordsIn acromegaly patients controlled on oral octreotide, growth hormone levels decreased compared with baseline.

    Peptide
    Octreotide
    Outcome
    DecreaseGH levels in controlled subjects
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    40 mg/d, escalated to 60 and then up to 80 mg/d · oralAs given in this study (human).

    Source sentences

    Summary
    When controlled on OOCs, GH levels were reduced compared to baseline, and acromegaly-related symptoms improved.
    4 context sentences
    Summary · context
    A novel oral octreotide formulation was tested for efficacy and safety in a phase III, multicenter, open-label, dose-titration, baseline-controlled study in patients with acromegaly.
    Summary · context
    We enrolled 155 complete or partially controlled patients (IGF-1 <1.3 × upper limit of normal [ULN], and 2-h integrated GH <2.5 ng/mL) receiving injectable somatostatin receptor ligand (SRL) for ≥ 3 months.
    Summary · context
    Subjects were switched to 40 mg/d oral octreotide capsules (OOCs), and the dose escalated to 60 and then up to 80 mg/d to control IGF-1.
    Summary · context
    Subsequent fixed doses were maintained for a 7-month core treatment, followed by a voluntary 6-month extension.
  5. 05HumanNon-randomized trialEfficacy outcome

    In acromegaly patients controlled on oral octreotide, acromegaly-related symptoms improved.

    In plain wordsIn acromegaly patients controlled on oral octreotide, disease-related symptoms improved.

    Peptide
    Octreotide
    Outcome
    Direction not reportedAcromegaly-related symptoms
    Study

    n: not reported in source

    Outcome group
    Overall treatment effect · Endocrine and hormones
    Studied dose
    40 mg/d, escalated to 60 and then up to 80 mg/d · oralAs given in this study (human).

    Source sentences

    Summary
    When controlled on OOCs, GH levels were reduced compared to baseline, and acromegaly-related symptoms improved.
    4 context sentences
    Summary · context
    A novel oral octreotide formulation was tested for efficacy and safety in a phase III, multicenter, open-label, dose-titration, baseline-controlled study in patients with acromegaly.
    Summary · context
    We enrolled 155 complete or partially controlled patients (IGF-1 <1.3 × upper limit of normal [ULN], and 2-h integrated GH <2.5 ng/mL) receiving injectable somatostatin receptor ligand (SRL) for ≥ 3 months.
    Summary · context
    Subjects were switched to 40 mg/d oral octreotide capsules (OOCs), and the dose escalated to 60 and then up to 80 mg/d to control IGF-1.
    Summary · context
    Subsequent fixed doses were maintained for a 7-month core treatment, followed by a voluntary 6-month extension.
  6. 06HumanNon-randomized trialEfficacy outcome

    In acromegaly patients receiving oral octreotide, 26 terminated early for treatment failure defined by IGF-1 ≥ 1.3 × ULN.

    In plain wordsIn acromegaly patients receiving oral octreotide, 26 stopped early because hormone control failed.

    Peptide
    Octreotide
    Outcome
    Not applicableEarly termination for treatment failure
    Study

    n: not reported in source

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    40 mg/d, escalated to 60 and then up to 80 mg/d · oralAs given in this study (human).

    Measurements

    Treatment failures
    26 subjects
    early termination
    IGF-1 threshold
    ≥ 1.3 × ULN
    treatment failure

    Source sentences

    Summary
    Twenty-six subjects who were considered treatment failures (IGF-1 ≥ 1.3 × ULN) terminated early, and 23 withdrew for adverse events, consistent with those known for octreotide or disease related.
    4 context sentences
    Summary · context
    A novel oral octreotide formulation was tested for efficacy and safety in a phase III, multicenter, open-label, dose-titration, baseline-controlled study in patients with acromegaly.
    Summary · context
    We enrolled 155 complete or partially controlled patients (IGF-1 <1.3 × upper limit of normal [ULN], and 2-h integrated GH <2.5 ng/mL) receiving injectable somatostatin receptor ligand (SRL) for ≥ 3 months.
    Summary · context
    Subjects were switched to 40 mg/d oral octreotide capsules (OOCs), and the dose escalated to 60 and then up to 80 mg/d to control IGF-1.
    Summary · context
    Subsequent fixed doses were maintained for a 7-month core treatment, followed by a voluntary 6-month extension.
  7. 07HumanNon-randomized trialSafety outcome

    In acromegaly patients receiving oral octreotide, 23 withdrew for adverse events consistent with known octreotide effects or disease-related events.

    In plain wordsIn acromegaly patients receiving oral octreotide, 23 withdrew for adverse events.

    Peptide
    Octreotide
    Outcome
    Not applicableWithdrawal for adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Endocrine and hormones
    Studied dose
    40 mg/d, escalated to 60 and then up to 80 mg/d · oralAs given in this study (human).

    Measurements

    Adverse-event withdrawals
    23 subjects
    oral octreotide

    Source sentences

    Summary
    Twenty-six subjects who were considered treatment failures (IGF-1 ≥ 1.3 × ULN) terminated early, and 23 withdrew for adverse events, consistent with those known for octreotide or disease related.
    4 context sentences
    Summary · context
    A novel oral octreotide formulation was tested for efficacy and safety in a phase III, multicenter, open-label, dose-titration, baseline-controlled study in patients with acromegaly.
    Summary · context
    We enrolled 155 complete or partially controlled patients (IGF-1 <1.3 × upper limit of normal [ULN], and 2-h integrated GH <2.5 ng/mL) receiving injectable somatostatin receptor ligand (SRL) for ≥ 3 months.
    Summary · context
    Subjects were switched to 40 mg/d oral octreotide capsules (OOCs), and the dose escalated to 60 and then up to 80 mg/d to control IGF-1.
    Summary · context
    Subsequent fixed doses were maintained for a 7-month core treatment, followed by a voluntary 6-month extension.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials3

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

3 trials · 2 completed · 3 with posted results · source ClinicalTrials.gov (opens in a new tab)

Status unknownPhase 3Results postedNCT03252353

Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

Chiasma, Inc.n = 561 Sept 2017 to est. May 2022

Acromegaly

Trial pageClinicalTrials.govUpdated 23 Nov 2020
CompletedPhase 3Results postedNCT02685709

Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly

Chiasma, Inc.n = 146Feb 2016 to Aug 2021

Acromegaly

Trial pageClinicalTrials.govUpdated 22 Apr 2022
CompletedPhase 3Results postedNCT01412424

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

Chiasma, Inc.n = 155Mar 2012 to May 2014

Acromegaly

Trial pageClinicalTrials.govUpdated 17 Aug 2017

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated · status corrected

  2. Version 1

    27 Oct 2026, 16:36 UTC

    First added · status corrected · source update from Europe PMC

Subjects

Terms as the source lists them.

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