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AcromegalyPhase 3MPOWEREDNCT02685709

Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly

A Phase 3 study testing Octreotide capsules in people with Acromegaly, run by Chiasma, Inc. at 53 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial (OPTMAL; NCT03252353), oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acromegaly
What is being tested?
Octreotide capsules
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
53 sitesin 13 countries
Study dates
Feb 2016to Aug 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of acromegaly
  • Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months
  • Biochemical control (IGF -1 < 1.3 x ULN and GH < 2.5ng/mL)

Who cannot join

  • Injections of long-acting somatostatin analogs, at a dosing interval > 8 weeks.
  • Pituitary radiotherapy within 5 years
  • Pituitary surgery within six months
  • Patients who previously participated in CH-ACM-01 study
  • Any clinically significant uncontrolled concomitant disease
  • Symptomatic cholelithiasis
Show all 10Show fewer
  • Previous treatment with:
  • Pegvisomant, within 12 weeks
  • Dopamine agonists, within 6 weeks
  • Pasireotide, within 12 weeks

Trial locations and contacts

53 sites in 13 countries.

53 sites in 13 countries

United States18 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Northwestern University

    Chicago, Illinois, 60611

  • John H. Stroger, Jr. Hospital of Cook County

    Chicago, Illinois, 60612

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43203

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist Research Institute

    Houston, Texas, 77030

  • Keck Medical Center of University of Southern California

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Rutgers - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • Columbia University Medical Center

    New York, New York, 10032

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Allegheny Endocrinology Associates

    Pittsburgh, Pennsylvania, 15212

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

Russia9 sites

  • Antrium Multidisciplinary Medical Clinic

    Barnaul, 656043

  • Interregional Clinical Diagnostic Center

    Kazan', 420101

  • Regional State Budgetary Healthcare Institution Regional State Hospital

    Krasnoyarsk, 660022

  • Sechenov Moscow First State Medical University

    Moscow, 119881

  • "Atlas" Medical Center

    Moscow, 121170

  • Vladimirsky Moscow Regional Research Clinical Institute

    Moscow, 129110

  • Novosibirsk State Regional Clinical Hospital

    Novosibirsk, 630087

  • Federal State Budgetary Institution "V. A. Almazov Federal North-West Medical Research Centre" of the Ministry of Health of the Russian Federation

    Saint Petersburg, 194156

  • "Centre Diabetes" LLC

    Samara, 443041

Other trials in Russia

Spain5 sites

  • Hospital Universitario de la Ribera

    Alzira, 46600

  • Hospital Universitari Germans Trias i Pujol

    Barcelona, 08916

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Complejo Hospitalario Universitario de Santiago de Compostela

    Santiago de Compostela, 15706

  • Campus Del Hospital Universitario Virgen del Rocio

    Seville, 46013

Other trials in Spain

United Kingdom4 sites

  • University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

    Birmingham, B15 2GW

  • Central Manchester University Hospitals NHS Foundation Trust, Manchester Royal Infirmary

    Manchester, M13 9WL

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

Other trials in United Kingdom

Hungary3 sites

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, H-1062

  • University of Pecs

    Pécs, H-7624

  • Szegedi Tudományegyetem, I. Belgyógyászati Klinika

    Szeged, H-6720

Other trials in Hungary

Italy3 sites

  • Policlinico di Monserrato U.O.C. Endocrinologia e Diabetologia

    Monserrato, 09042

  • Università di Pisa Dipartimento di Medicina Clinica e Sperimentale

    Pisa, 56124

  • Fondazione Policlinico Universitario A. Gemelli Università Cattolica del S.Cuore S.C. Endocrinologia e Malattie del Metabolismo

    Rome, 00168

Other trials in Italy

Austria2 sites

  • Universitätsklinik für Innere Medizin Klinische Abteilung für Endokrinologie und Diabetologie

    Graz, A-8036

  • Medizinische Universität Wien

    Vienna, A-1090

Other trials in Austria

France2 sites

  • Hospices Civils de Lyon

    Bron, 69677

  • Hôpital Bicêtre APHP

    Le Kremlin-Bicêtre, 94275

Other trials in France

Lithuania2 sites

  • Hospital of LUHS Kauno Klinikos

    Kaunas, LT-50009

  • Vaidotas Urbanavicius Individuali Imonė

    Vilnius, LT-10207

Other trials in Lithuania

Poland2 sites

  • Katedra i Klinika Endokrynologii i Chorob Wewnetrznych Gdanski Uniwersytet Medyczny

    Gdansk, 80-211

  • Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami

    Wroclaw, 50-367

Other trials in Poland

Germany1 site

  • Praxis für Endokrinologie und Diabetologie Dr M Droste

    Oldenburg, 26122

Other trials in Germany

Romania1 site

  • "C.I. Parhon" National Institute of Endocrinology I Clinical Endocrinology Department - Endemic goitier and its complications

    Bucharest, 011863

Other trials in Romania

Serbia1 site

  • Clinical Centre of Serbia, Clinic for Endocrinology Diabetes and Metabolic Diseases

    Belgrade, 11 000

Other trials in Serbia

About this study

Official title: A Phase 3, Randomized, Active Controlled Study to Evaluate Maintenance of Response, Safety and Patient Reported Outcomes in Acromegaly Patients Treated With Octreotide Capsules vs. Parenteral Somatostatin Receptor Ligands

Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial (OPTMAL; NCT03252353), oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref).

The objective of this study was to compare the efficacy, safety, and patient reported outcomes (PROs) between oral octreotide capsules and injectable somatostatin receptor ligands (SRLs).

Read the detailed description

This was phase 3, randomized, open-label, active controlled, multicenter study to evaluate the maintenance of response, safety and patient reported outcomes (PROs) in acromegaly patients treated with octreotide capsules and in patients treated with standard of care parenteral somatostatin receptor ligands (SRLs), who previously tolerated and demonstrated biochemical control on both treatments.

The core study consisted of three phases: a Screening phase, Run-in phase and a Randomized Controlled Treatment (RCT) phase.

Eligible patients who were biochemically controlled on parenteral SRLs were switched to octreotide capsules for a 26-week period Run-in phase. During this phase the effective dose for each patient was determined through dose titration.

Patients whose acromegaly has been controlled biochemically on octreotide capsules at the end of the Run-in phase entered a 36-week open-label RCT phase, where they randomized to continue on octreotide capsules or switch back to their injectable SRL treatment (as received prior to Screening).

Following the completion of the core study (Screening, Run-in and RCT phases), eligible patients were offered to enter the Study Extension phase and receive octreotide capsules until product marketing or study termination.

A Sub-study, performed in selected non-European sites, allowed patients with inadequate biochemical control on octreotide capsules during the Run-in phase to enter a Combination phase and receive co-administration of octreotide capsules with cabergoline tablets for a total of 36 weeks.

Conditions
Acromegaly
Being tested
Octreotide capsules
Keywords
Octreotide Capsules, Acromegaly, somatostatin receptor ligands (SRLs), Mpowered, OOC-ACM-302
Medical subject headings
Acromegaly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Octreotide capsulesDrug

    Also called Injection SRLs

Study groups in NCT02685709
Study groupRoleWhat they receive
Run-in phaseExperimentalOral octreotide capsules
Receives: Drug: Octreotide capsules
RCT phase - OralExperimentalOral octreotide capsules
Receives: Drug: Octreotide capsules
RCT phase - InjectablesActive comparatorInjectable somatostatin analogs (octreotide or lanreotide)
Receives: Drug: Octreotide capsules
Combination phase (sub-study)ExperimentalOctreotide capsules plus cabergoline
Receives: Drug: Octreotide capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase

    Proportion of patients who are biochemically controlled throughout the RCT phase. A patient was considered biochemically controlled if IGF-1 Time Weighted Average (TWA) during the RCT phase is <1.3 ULN

    Measured: 62 weeks

Secondary outcomes (6)

  1. Proportion of Patients With Clinical and Biochemical Control at the End of the RCT Phase

    Proportion of patients with clinical and biochemical control at the end of the RCT phase. Patients were considered biochemically and clinically controlled if they met both of the following criteria:

    • Their IGF-1 TWA during the RCT phase was <1.3 times ULN
    • Their AIS score at week 62/EOT was maintained or reduced compared to week 26 (start of RCT phase)

    Measured: Week 62/ End of treatment; EOT

  2. Proportion of Patients Who Maintain or Reduce the Overall Number of Active Acromegaly Symptoms at the End of the RCT Phase

    Proportion of patients who maintain or reduce the overall number of active acromegaly symptoms at the end of the RCT phase (week 62/ EOT) , compared to week 26 (start of the RCT phase

    Measured: 62 weeks

  3. Proportion of Patients Who Maintain or Improve Their Overall Acromegaly Index of Severity (AIS) Score at the End of the RCT Phase

    Proportion of patients who maintain or improve their overall Acromegaly index of severity (AIS) score at the end of the RCT phase (improvement defined as a reduction of at least one point in the AIS score), compared to week 26 (start of the RCT phase)

    Measured: 62 weeks

  4. Proportion of Patients of Those Completing the RCT Phase Who Entered the Study Extension Phase

    Proportion of patients of those completing the RCT phase (at a time octreotide capsules were not commercially available at the specific country), who entered the Study Extension phase, overall and by treatment group

    Measured: 62 weeks

  5. Change in IGF-1 Levels in the RCT Phase

    Change in IGF-1 levels from the start of the randomized phase to the end of RCT phase.

    Complete Responder (CR) is defined as IGF-1 ≤ 1 x ULN; Partial Responder (PR) is defined as 1 x ULN < IGF-1 < 1.3 x ULN, and Non-Responder (NR): IGF-1 ≥ 1.3 x ULN

    Measured: Change from Week 26 to week 62

  6. Change in GH Levels in the RCT Phase

    Change in GH levels from the start of the randomized phase through the end of RCT phase.

    Measured: Change from Week 26 to week 62

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionOct 2020
  4. Study completionAug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02685709
Sponsor's protocol ID
OOC-ACM-302
Other IDs
2015-002854-11, 2015
Acronym
MPOWERED
Status last verified
Mar 2022
First submitted
28 Jan 2016
Last updated
22 Apr 2022
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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, 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. Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial. J Clin Endocrinol Metab. 2015 Apr;100(4):1699-708. doi: 10.1210/jc.2014-4113. Epub 2015 Feb 9.

    PubMed 25664604

  • Melmed S. New therapeutic agents for acromegaly. Nat Rev Endocrinol. 2016 Feb;12(2):90-8. doi: 10.1038/nrendo.2015.196. Epub 2015 Nov 27.

    PubMed 26610414

  • Fleseriu M, Dreval A, Bondar I, Vagapova G, Macut D, Pokramovich YG, Molitch ME, Leonova N, Raverot G, Grineva E, Poteshkin YE, Gilgun-Sherki Y, Ludlam WH, Patou G, Haviv A, Gordon MB, Biermasz NR, Melmed S, Strasburger CJ. Maintenance of response to oral octreotide compared with injectable somatostatin receptor ligands in patients with acromegaly: a phase 3, multicentre, randomised controlled trial. Lancet Diabetes Endocrinol. 2022 Feb;10(2):102-111. doi: 10.1016/S2213-8587(21)00296-5. Epub 2021 Dec 22.

    PubMed 34953531

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Octreotide capsules in people with Acromegaly, run by Chiasma, Inc. at 53 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Russia, Spain, United Kingdom, Hungary and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase (time frame: 62 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02685709, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.

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