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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04076462
Other study ID # HS-18-633
Secondary ID 2019-001191-11
Status Completed
Phase Phase 3
First received
Last updated
Start date August 19, 2019
Est. completion date May 2, 2023

Study information

Verified date April 2024
Source Camurus AB
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this trial is to assess the efficacy and safety of CAM2029 in patients with acromegaly. Patients will be randomized to either CAM2029 or placebo administered subcutaneously once monthly during 6 months.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date May 2, 2023
Est. primary completion date May 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female patients, =18 years at screening - Able to provide written informed consent to participate in the trial prior to any trial related procedures are performed - Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly - Treatment with a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as monotherapy prior to screening - IGF-1 levels =1xULN at screening - Adequate liver, pancreatic, renal and bone marrow functions - Normal ECG Exclusion Criteria: - GH =2.5 µg/L at screening (cycle) - Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening [whichever is longer] - Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks) - Patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated - Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening - Patients who have undergone pituitary surgery within 6 months prior to screening - Patients who have received prior pituitary irradiation - Patients with poorly controlled diabetes mellitus (hemoglobin A1c >8.0%)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CAM2029 (octreotide subcutaneous depot)
Octreotide subcutaneous depot for monthly injections in acromegaly patients
Matching placebo
Matching placebo for CAM2029

Locations

Country Name City State
Germany Universitätsklinikum Essen Essen
Germany Universitätsklinikum Frankfurt, Medizinische Klinik 1, Schwerpunkt Endokrinologie, Diabetologie, Ernährungsmedizin Frankfurt
Germany Universitätsklinikum Freiburg Freiburg
Germany LMU Clinic of University of Munich, Medical Clinic and Polyclinic IV Munich
Germany Medicover Neuroendokrinologie Munich
Germany Medicover Oldenburg MVZ Oldenburg
Greece Aretaeio University Hospital Endocrinology Department, Faculty of Diabetes and Metabolism Athens
Greece General Hospital of Athens "Laiko", Endocrinology University Clinic Athens
Greece General Hospital of Thessaloniki "Ippokratio" Thessaloníki
Hungary Military Healt Center, 2nd Department of Internal Medicine Budapest
Hungary SZTE ÁOK I.sz. Belgyógyászati Klinika Szeged
Italy IRCCS Policlinico San Martino Genova
Italy Azienda Universitaria "Federico II" Napoli
Italy Azienda Ospedaliera Padova, Department of Internal medicine Padova
Italy Policlinic Gemelli University Hospital IRCCS, Department of Endocrinology Roma
Italy AOUI Verona, Policlinic of GB Rossi Verona
Poland Centrum Nowoczesnych Terapii "Dobry Lekarz" Kraków
Poland Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie Kraków
Poland Amicare Sp. z o.o. Sp. K. Lodz
Poland Piekarskie Centrum Medyczne, Szpital Miejski Piekary Slaskie
Russian Federation Interregional Clinical Diagnostic Center Kazan
Russian Federation "Atlas" Medical Center Moscow
Russian Federation Sechenov Moscow First State Medical University Moscow
Russian Federation Vladimirsky Moscow Regional Research Clinical Institute Moscow
Russian Federation Novosibirsk State Regional Clinical Hospital Novosibirsk
Russian Federation Interregional Clinical Diagnostic Center Ryazan'
Russian Federation Saratov Regional Clinic Hospital Saratov
Spain University Hospital of Alicante Alicante
Spain Hospital Universitario Vall d'Hebron Barcelona
Spain University Hospital Complex A Coruña Coruña
Spain Hospital Universitario Gregorio Marañón Madrid
Spain Hospital Universitario La Princesa Madrid
Spain Complejo Hospitalario Universitario Santiago de Compostela Santiago de Compostela
Spain University Hospital Virgen del Rocio Sevilla
Spain Hospital Universitario de la Ribera Valencia
Spain Hospital Universitario y Politécnico La Fe Valencia
Turkey Akdeniz University Faculty of Medicine Department of Endocrinology Antalya
Turkey Aydin Adnan Menderes University Research and Application Hospital Aydin
Turkey Pamukkale University Faculty of Medicine Department of Endocrinology Denizli
Turkey Eskisehir Osmangazi University Medical Faculty Eskisehir
Turkey Istanbul University Medical Faculty Fatih
Turkey Kocaeli University Faculty of Medicine Department of Endocrinology and Metabolism Kocaeli
Turkey Inonu University Medical Faculty Endocrinology Department Malatya
Turkey Erciyes University Medical Faculty, Dept. of Endocrinology Melikgazi
Turkey Karadeniz Technical University Farabi Hospital Trabzon
Turkey Zonguldak Bulent Ecevit University Department of Internal Medicine, Division of Endocrinology and Metabolism Ibni Sina Campus Zonguldak
United Kingdom College of Medical and Dental Sciences Birmingham
United Kingdom University Hospitals Coventry and Warwickshire NHS Trust Coventry
United Kingdom Leeds Teaching Hospitals NHS Trust Leeds
United Kingdom The Christie NHS Foundation Trust Manchester
United Kingdom Salford Royal Foundation Trust Salford
United States University of Michigan Ann Arbor Michigan
United States University of Cincinnati Cincinnati Ohio
United States Research Institute of Dallas Dallas Texas
United States Palm Research Center Las Vegas Nevada
United States UCLA Department of Medicine Division of Endocrinology Los Angeles California
United States Prufen Clinical Research LLC Miami Florida
United States Columbia University Medical Center New York New York
United States Stanford University Medical Center Palo Alto California
United States Thomas Jefferson University Philadelphia Pennsylvania
United States Allegheny Endocrinology Associates Pittsburgh Pennsylvania
United States Mayo Clinic Rochester Minnesota
United States Washington University in St. Louis, School of Medicine Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Camurus AB

Countries where clinical trial is conducted

United States,  Germany,  Greece,  Hungary,  Italy,  Poland,  Russian Federation,  Spain,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with mean IGF-1 levels =1xULN Week 22 and 24
Secondary Proportion of patients with mean IGF-1 levels =1xULN, including patients with dose reduction Week 22 and 24
Secondary Proportion of patients with mean IGF-1 levels =1xULN at Week 22/Week 24 and mean GH levels <2.5 µg/L at Week 24 Week 22 and 24
Secondary Proportion of patients with mean GH levels <2.5 µg/L Week 24
Secondary Proportion of patients with mean GH levels <1.0 µg/L Week 24
Secondary Incidence of treatment emergent adverse events Week 0 to 24
Secondary Proportion of patients/partners declared competent by a healthcare professional to administer intervention During patients/partners first three attempts during the trial period of 24 weeks whenever these visits take place Week 0 to 20 and week 24
Secondary Octreotide plasma concentrations over time Week 0 to 24
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