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AcromegalyPhase 3NCT01412424

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

A Phase 3 study testing Octreotide capsules in people with Acromegaly, run by Chiasma, Inc. at 36 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

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. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
36 sitesin 13 countries
Study dates
Mar 2012to May 2014
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

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

36 sites in 13 countries.

36 sites in 13 countries

Germany5 sites

  • Campus Charité Mitte

    Berlin

  • ENDOC Center for Endocrine Tumors

    Hamburg, 20357

  • Medizinische Klinik Innenstadt

    Munich, 80336

  • Max Planck Institute of Psychiatry

    Munich, 80804

  • Praxis for Endocrimology and Diabetology in Oldenburg

    Oldenburg, 26122

Other trials in Germany

Poland5 sites

  • Autonomous Public Clinical Hospital No. 5

    Katowice, 40- 952

  • Department of Endocrinology - Jagiellonian University, Krakow

    Krakow, 31-501

  • Clinical Hospital of Medical University in Poznan

    Poznan, 60-355

  • Bielanski Hospital

    Warsaw, 01 - 809

  • Wroclaw Medical University

    Wroclaw, 50-367

Other trials in Poland

Hungary4 sites

  • Military Hospital, State Health Center 2nd Department of Internal Medicine

    Budapest, 1062

  • Semmelweiss University

    Budapest, 1088

  • University of Pecs

    Pécs, 7624

  • University of Szeged

    Szeged, 6720

Other trials in Hungary

United Kingdom4 sites

  • University of Warwick - Medical School

    Coventry, CV2 2DX

  • St Bartholomew's Hospital West

    London, EC1M 6BQ

  • The Christie Hospital NHS Trust

    Manchester, M13 9WL

  • Oxford Centre for Diabetes, Endocrinology and Metabolism

    Oxford, OX37LJ

Other trials in United Kingdom

Italy3 sites

  • Servizio di Endocrinologia A.O. Spedali Civili di Brescia

    Brescia, 25128

  • Dipartimento Clinico Sperimentale di Medicina e Farmacologia

    Messina, 98125

  • Ospedale Molinette

    Torino, 10126

Other trials in Italy

Mexico3 sites

  • Unidad de Investigacion Clinica Cardiometabolica de Occidente

    Guadalajara Jalisco, 44150

  • Instituto Nacional de Neurologia y Neurocirugía - National Institute of Neurology and Neurosurgery

    Mexico City, 14269

  • Centro Medico ABC

    Mexico City, 5300

Other trials in Mexico

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kauno Klinikos

    Kaunas, 50009

  • Vilnius University Hospital Santariskiu Clinics Center of Endocrinology

    Vilnius, 8661

Other trials in Lithuania

Netherlands2 sites

  • Leiden University Medical Centre

    Leiden, 2333 ZA

  • Erasmus University Medical Center

    Rotterdam, 3015 CE

Other trials in Netherlands

Romania2 sites

  • Endocrinology Institute C.I.Parhon

    Bucharest, 11863

  • County Emergency Hospital, Sf. Spiridon, Department of Endocrinology

    Iași, 700111

Other trials in Romania

Serbia2 sites

  • Clinic for Endocrinology, Diabetes and Metabolism Diseases, Clinical Center of Serbia

    Belgrade, 11000

  • Clinical Center of Vojvodina

    Novi Sad, 21000

Other trials in Serbia

Slovakia2 sites

  • University Hospital Bratislava, Hospital of L.Derer

    Bratislava, 833 05

  • National Institute of Endocrinology and Diabetology

    Ľubochňa, 034 91

Other trials in Slovakia

United States1 site

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

Slovenia1 site

  • Department of Endocrinology and Diabetes, University Medical Centre

    Ljubliana, 1525

Other trials in Slovenia

About this study

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

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.

Read the detailed description

The study consisted of 2 periods, a Core Treatment Period of up to 7 months and an optional Extension Treatment Period of up to 6 months, for a total study duration of up to 13 months. The Core Treatment Period consisted of 2 phases, a Dose Escalation Phase of at least 2 months to identify the therapeutic dose for each study participant and a Fixed Dose Phase of 2 to 5 months during which the therapeutic dose was maintained.

Participants were eligible to enter the Fixed Dose Phase of the Core Treatment Period if they were clinically and biochemically controlled. The same criteria were used to allow entry into the voluntary 6-month Extension Treatment Period.

The Core Treatment Period of the study was completed if the participant had at least 2 months of treatment in the Fixed Dose Phase and a total treatment duration of at least 7 months. Participants who elected to continue into the Extension Treatment Period maintained their therapeutic dose during this period. At the end of the study (after the last dose of MYCAPSSA in either the Core Treatment Period or the Extension Treatment Period), there was a 2-week follow-up period for safety assessments.

Conditions
Acromegaly
Being tested
Octreotide capsules
Keywords
acromegaly, IGF-1, growth hormone, Octreolin, octreotide, somatostatin analog
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 MYCAPSSA™, Formerly known as Octreolin™

    Octreotide was provided in hard gelatin capsules.

Study groups in NCT01412424
Study groupRoleWhat they receive
Octreotide capsulesExperimentalParticipants 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.
Receives: Drug: Octreotide capsules

What is being measured

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

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

    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.

    Measured: End of the core treatment period (up to 7 months)

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

    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.

    Measured: End of the extension treatment period (up to 13 months)

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

    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.

    Measured: Baseline and the end of the core treatment period (up to 7 months)

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

    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.

    Measured: Beginning of the fixed dose phase of the core treatment period and the end of the core treatment period (up to 7 months)

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

    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.

    Measured: Beginning and the end of the extension treatment period (up to 6 months)

  4. Maintenance of Response During the Extension Treatment Period

    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.

    Measured: Beginning of the extension treatment period and the end of the extension treatment period (up to 13 months)

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

    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.

    Measured: Baseline and the end of the extension treatment period (up to 13 months)

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

    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.

    Measured: Baseline and the end of the extension treatment period (up to 13 months)

Timeline

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

  1. First posted9 Aug 2011 (estimated)
  2. Study startMar 2012
  3. Primary completionMay 2014
  4. Study completionMay 2014

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01412424
Sponsor's protocol ID
CH-ACM-01
Status last verified
Jul 2017
First submitted
5 Aug 2011
Last updated
17 Aug 2017
Data monitoring committee
Yes

Publications

  • Labadzhyan A, Nachtigall LB, Fleseriu M, Gordon MB, Molitch M, Kennedy L, Samson SL, Greenman Y, Biermasz N, Bolanowski M, Haviv A, Ludlam W, Patou G, Strasburger CJ. Oral octreotide capsules for the treatment of acromegaly: comparison of 2 phase 3 trial results. Pituitary. 2021 Dec;24(6):943-953. doi: 10.1007/s11102-021-01163-2. Epub 2021 Jun 25.

    PubMed 34173129

  • 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

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 36 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 6 inclusion and 11 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 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Germany, Poland, Hungary, United Kingdom, Italy 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 1 Dec 2015). 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?

Percentage of Responders at the End of the Core Treatment Period (time frame: End of the core treatment period (up to 7 months)). The study lists 2 primary outcomes in all. 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 NCT01412424, which also lists 2 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 17 Aug 2017.

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