Acromegaly Clinical Trial
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.
Status | Completed |
Enrollment | 155 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Campus Charité Mitte | Berlin | |
Germany | ENDOC Center for Endocrine Tumors | Hamburg | |
Germany | Max Planck Institute of Psychiatry | Munich | |
Germany | Medizinische Klinik Innenstadt | Munich | |
Germany | Praxis for Endocrimology and Diabetology in Oldenburg | Oldenburg | |
Hungary | Military Hospital, State Health Center 2nd Department of Internal Medicine | Budapest | |
Hungary | Semmelweiss University | Budapest | |
Hungary | University of Pecs | Pecs | |
Hungary | University of Szeged | Szeged | |
Israel | Hadassah Ein-Karem Medical Center | Jerusalem | |
Israel | Beilinson Hospital | Petach Tikva | |
Israel | Tel Aviv Sourasky Medical Center | Tel Aviv | |
Italy | Servizio di Endocrinologia A.O. Spedali Civili di Brescia | Brescia | |
Italy | Dipartimento Clinico Sperimentale di Medicina e Farmacologia | Messina | |
Italy | Ospedale Molinette | Torino | |
Lithuania | Hospital of Lithuanian University of Health Sciences Kauno Klinikos | Kaunas | |
Lithuania | Vilnius University Hospital Santariskiu Clinics Center of Endocrinology | Vilnius | |
Mexico | Unidad de Investigacion Clinica Cardiometabolica de Occidente | Guadalajara Jalisco | |
Mexico | Instituto Nacional de Neurologia y Neurocirugía - National Institute of Neurology and Neurosurgery | Mexico City | |
Mexico | Centro Medico ABC | Mexico D.F. | |
Netherlands | Leiden University Medical Centre | Leiden | |
Netherlands | Erasmus University Medical Center | Rotterdam | |
Poland | Autonomous Public Clinical Hospital No. 5 | Katowice | |
Poland | Department of Endocrinology - Jagiellonian University, Krakow | Krakow | |
Poland | Clinical Hospital of Medical University in Poznan | Poznan | |
Poland | Bielanski Hospital | Warsaw | |
Poland | Wroclaw Medical University | Wroclaw | |
Romania | Endocrinology Institute C.I.Parhon | Bucharest | |
Romania | County Emergency Hospital, Sf. Spiridon, Department of Endocrinology | Iasi | |
Serbia | Clinic for Endocrinology, Diabetes and Metabolism Diseases, Clinical Center of Serbia | Belgrade | |
Serbia | Clinical Center of Vojvodina | Novi Sad | |
Slovakia | University Hospital Bratislava, Hospital of L.Derer | Bratislava | |
Slovakia | National Institute of Endocrinology and Diabetology | Lubochna | |
Slovenia | Department of Endocrinology and Diabetes, University Medical Centre | Ljubliana | |
United Kingdom | University of Warwick - Medical School | Coventry | |
United Kingdom | St Bartholomew's Hospital West | London | |
United Kingdom | The Christie Hospital NHS Trust | Manchester | |
United Kingdom | Oxford Centre for Diabetes, Endocrinology and Metabolism | Oxford | |
United States | Cedars-Sinai Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Chiasma, Inc. |
United States, Germany, Hungary, Israel, Italy, Lithuania, Mexico, Netherlands, Poland, Romania, Serbia, Slovakia, Slovenia, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | End of the core treatment period (up to 7 months) | No |
Primary | 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. | End of the extension treatment period (up to 13 months) | No |
Secondary | 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. | Baseline and the end of the core treatment period (up to 7 months) | No |
Secondary | 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. | Beginning of the fixed dose phase of the core treatment period and the end of the core treatment period (up to 7 months) | No |
Secondary | 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. | Beginning and the end of the extension treatment period (up to 6 months) | No |
Secondary | 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. | Beginning of the extension treatment period and the end of the extension treatment period (up to 13 months) | No |
Secondary | 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. | Baseline and the end of the extension treatment period (up to 13 months) | No |
Secondary | 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. | Baseline and the end of the extension treatment period (up to 13 months) | No |
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