- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01412424
Efficacy and Safety of Octreotide (MYCAPSSA™ [Formerly Octreolin™]) for Acromegaly
Efficacy and Safety of Oral Octreolin™ in Patients With Acromegaly Who Are Currently Receiving Parenteral Somatostatin Analogs
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Berlin, Germany
- Campus Charite Mitte
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Hamburg, Germany, 20357
- ENDOC Center for Endocrine Tumors
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Munich, Germany, 80336
- Medizinische Klinik Innenstadt
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Munich, Germany, 80804
- Max Planck Institute of Psychiatry
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Oldenburg, Germany, 26122
- Praxis for Endocrimology and Diabetology in Oldenburg
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Budapest, Hungary, 1062
- Military Hospital, State Health Center 2nd Department of Internal Medicine
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Budapest, Hungary, 1088
- Semmelweiss University
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Pecs, Hungary, 7624
- University of Pecs
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Szeged, Hungary, 6720
- University of Szeged
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Brescia, Italy, 25128
- Servizio di Endocrinologia A.O. Spedali Civili di Brescia
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Messina, Italy, 98125
- Dipartimento Clinico Sperimentale di Medicina e Farmacologia
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Torino, Italy, 10126
- Ospedale Molinette
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Kaunas, Lithuania, 50009
- Hospital of Lithuanian University of Health Sciences Kauno Klinikos
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Vilnius, Lithuania, 8661
- Vilnius University Hospital Santariskiu Clinics Center of Endocrinology
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Guadalajara Jalisco, Mexico, 44150
- Unidad de Investigacion Clinica Cardiometabolica de Occidente
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Mexico City, Mexico, 14269
- Instituto Nacional de Neurologia y Neurocirugía - National Institute of Neurology and Neurosurgery
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Mexico D.F., Mexico, 5300
- Centro Médico ABC
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Leiden, Netherlands, 2333 ZA
- Leiden University Medical Centre
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Rotterdam, Netherlands, 3015 CE
- Erasmus University Medical Center
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Katowice, Poland, 40- 952
- Autonomous Public Clinical Hospital No. 5
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Krakow, Poland, 31-501
- Department of Endocrinology - Jagiellonian University, Krakow
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Poznan, Poland, 60-355
- Clinical Hospital of Medical University in Poznan
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Warsaw, Poland, 01 - 809
- Bielanski Hospital
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Wroclaw, Poland, 50-367
- Wroclaw Medical University
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Bucharest, Romania, 11863
- Endocrinology Institute C.I.Parhon
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Iasi, Romania, 700111
- County Emergency Hospital, Sf. Spiridon, Department of Endocrinology
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Belgrade, Serbia, 11000
- Clinic for Endocrinology, Diabetes and Metabolism Diseases, Clinical Center of Serbia
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Novi Sad, Serbia, 21000
- Clinical Center of Vojvodina
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Bratislava, Slovakia, 833 05
- University Hospital Bratislava, Hospital of L.Derer
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Ľubochňa, Slovakia, 034 91
- National Institute of Endocrinology and Diabetology
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Ljubliana, Slovenia, 1525
- Department of Endocrinology and Diabetes, University Medical Centre
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Coventry, United Kingdom, CV2 2DX
- University of Warwick - Medical School
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London, United Kingdom, EC1M 6BQ
- St Bartholomew's Hospital West
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Manchester, United Kingdom, M13 9WL
- The Christie Hospital NHS Trust
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Oxford, United Kingdom, OX37LJ
- Oxford Centre for Diabetes, Endocrinology and Metabolism
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Octreotide was provided in hard gelatin capsules.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Responders at the End of the Core Treatment Period
Time Frame: End of the core treatment period (up to 7 months)
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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.
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End of the core treatment period (up to 7 months)
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Percentage of Responders at the End of the Extension Treatment Period
Time Frame: End of the extension treatment period (up to 13 months)
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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.
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End of the extension treatment period (up to 13 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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)
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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.
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Baseline and the end of the core treatment period (up to 7 months)
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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)
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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.
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Beginning of the fixed dose phase of the core treatment period and the end of the core treatment period (up to 7 months)
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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)
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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.
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Beginning and the end of the extension treatment period (up to 6 months)
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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)
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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.
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Beginning of the extension treatment period and the end of the extension treatment period (up to 13 months)
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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)
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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.
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Baseline and the end of the extension treatment period (up to 13 months)
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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)
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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.
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Baseline and the end of the extension treatment period (up to 13 months)
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Shlomo Melmed, MD, Cedars-Sinai Medical Center
Publications and helpful links
General 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. Erratum In: Pituitary. 2021 Aug 4;:
- 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. Erratum In: J Clin Endocrinol Metab. 2016 Oct;101(10 ):3863. J Clin Endocrinol Metab. 2020 Dec 1;105(12):
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Endocrine System Diseases
- Musculoskeletal Diseases
- Hypothalamic Diseases
- Bone Diseases
- Bone Diseases, Endocrine
- Hyperpituitarism
- Pituitary Diseases
- Acromegaly
- Antineoplastic Agents
- Gastrointestinal Agents
- Antineoplastic Agents, Hormonal
- Octreotide
Other Study ID Numbers
- CH-ACM-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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