Evidence map›Paper›PMID 34173129›Full record

Trial reportPituitary2021

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

Artak Labadzhyan, L B Nachtigall, M Fleseriu, M B Gordon, M Molitch, L Kennedy, S L Samson, Y Greenman, N Biermasz, M Bolanowski and 4 more

Erratum issued 2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pituitary, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01412424 phase3completednot on this map

Efficacy and Safety of Oral Octreolin™ in Patients With Acromegaly Who Are Currently Receiving Parenteral Somatostatin Analogs

TypeinterventionalSponsorChiasma, Inc.Ran2012 to 2014Enrolled155ConditionsAcromegalyArmsOctreotide capsules
NCT03252353 phase3unknown statusnot on this map

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

TypeinterventionalSponsorChiasma, Inc.Ran2017 to 2022Enrolled56ConditionsAcromegalyArmsoctreotide capsules, Matching placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Current treatment landscape of acromegaly.The Journal of clinical endocrinology and metabolism · 2026
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 12 institutions in 5 countries.

Artak LabadzhyanCedars-Sinai Medical Center, Los Angeles, CA, 90048, USA. Artak.Labadzhyan@cshs.org.
L B NachtigallMGH Neuroendocrine and Pituitary Center, Chestnut Hill, MA, USA.
M FleseriuPituitary Center, Oregon Health & Sciences University, Portland, OR, USA.ORCID http://orcid.org/0000-0001-9284-6289
M B GordonAllegheny Neuroendocrinology Center, Allegheny General Hospital, Pittsburgh, PA, USA.
M MolitchNorthwestern University, Chicago, IL, USA.
L KennedyCleveland Clinic Foundation, Cleveland, OH, USA.
S L SamsonMayo Clinic, Jacksonville, FL, USA.ORCID http://orcid.org/0000-0002-8159-7093
Y GreenmanSourasky Medical Center and Tel Aviv University, Tel Aviv, Israel.ORCID http://orcid.org/0000-0003-4923-488X
N BiermaszLeiden University Medical Center, Leiden, The Netherlands.ORCID http://orcid.org/0000-0001-5817-3594
M BolanowskiWroclaw Medical University, Wroclaw, Poland.ORCID http://orcid.org/0000-0002-2360-6596
A HavivChiasma, Inc., Needham, MA, USA.
W LudlamCedars-Sinai Medical Center, Los Angeles, CA, 90048, USA.
G PatouChiasma, Inc., Needham, MA, USA.
C J StrasburgerCharite Universitatsmedizin, Berlin, Germany.ORCID http://orcid.org/0000-0001-7905-7357
Cedars-Sinai Medical Center · USChiasma (United States) · USAllegheny General Hospital · USCharité - Universitätsmedizin Berlin · DEChestnut Hill College · USCleveland Clinic · USJacksonville College · USLeiden University Medical Center · NLNorthwestern University · USOregon Health & Science University · USTel Aviv University · ILWroclaw Medical University · PL

Funding

Chiasma Inc. Chiasma Inc.
6 · The paper itself

Abstract

purposeResults are presented from 2 to 3 trials investigating oral octreotide capsules (OOC) as an alternative to injectable somatostatin receptor ligands (iSRLs) in the treatment of acromegaly.

methodsCH-ACM-01 was an open-label trial (N = 155) and CHIASMA OPTIMAL was a double-blind placebo-controlled (DPC) trial (N = 56), both investigating OOC as maintenance therapy for patients with acromegaly who were biochemical responders receiving iSRLs.

resultsBaseline characteristics in both trials reflected those expected of patients with acromegaly responding to treatment and were similar between trials, despite differences in inclusion criteria. OOC demonstrated a consistent degree of biochemical response across trials, with 65% of patients in CH-ACM-01 maintaining response during the core period and 64% of patients in CHIASMA OPTIMAL at the end of the DPC. Mean insulin-like growth factor I (IGF-I) levels remained within inclusion criteria at the end of treatment in both trials. Of 110 patients entering the fixed-dose phase in CH-ACM-01, 80% maintained or improved acromegaly symptoms from baseline to the end of treatment. Over 85% of patients in both trials elected to continue into the extension phases. OOC were found to be well tolerated across both trials, and no dose-related adverse events were observed.

conclusionsOOC demonstrated remarkably consistent results for biochemical response, durability of response, and preference to continue with oral treatment across these 2 complementary landmark phase 3 trials, despite differences in the design of each. Trial registration NCT03252353 (August 2017), NCT01412424 (August 2011).

Indexed as

AcromegalyHuman Growth HormoneCapsulesHumansInsulin-Like Growth Factor IOctreotideSomatostatinCapsulesHuman Growth HormoneInsulin-Like Growth Factor IOctreotideSomatostatinAcromegalyGrowth hormoneIGF-IOral octreotideSomatostatin analogsSomatostatin receptor ligands

Identifiers

PMID34173129
PMCPMC8550586
OpenAlexW3176646245

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.