Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00600886
First received: January 14, 2008
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

The patients will receive either Pasireotide LAR or Octreotide LAR for one year of treatment.

The objective of this study is to compare the proportion of patients with a reduction of mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12 months.

Following one year of treatment patients may proceed into the study extension. Patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) will be switched to the other treatment arm at month 13.


Condition Intervention Phase
Acromegaly
Drug: Pasireotide
Drug: Octreotide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Mean growth hormone (GH) level and insulin like growth factor-1 (IGF-1) level,12 months. [ Time Frame: At 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of pasireotide LAR and octreotide LAR on tumor volume at 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
  • Effect of pasireotide LAR and octreotide LAR on normalization of IGF-1 at 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
  • Effect of pasireotide LAR and octreotide LAR on the reduction of mean GH level AND normalization of IGF-1 at month 6 and 9 [ Time Frame: At 6 months & at 12 months ] [ Designated as safety issue: No ]
  • Effect of pasireotide LAR and octreotide LAR on health related quality of life at 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: No ]

Enrollment: 533
Study Start Date: February 2008
Estimated Study Completion Date: June 2014
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOM230 LAR @ 40mg
SOM230 LAR @ 40mg
Drug: Pasireotide
SOM230 LAR
Active Comparator: Octreotide LAR @ 20 mg
Octreotide LAR @ 20 mg
Drug: Octreotide
Sandostatin LAR
Other Name: Octrotide LAR

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with active acromegaly (based on elevated GH and IGF-1 levels)
  • Patients who have undergone one or more pituitary surgeries, but have not been treated medically, or de-novo patients presenting a visible pituitary adenoma on MRI and who refuse pituitary surgery or for whom pituitary surgery is contraindicated
  • Patients for whom written informed consent to participate in the study has been obtained prior to any study related activity

Exclusion criteria:

  • Patients who are being or were treated with octreotide, lanreotide, dopamine agonists or GH antagonists with the exception of a single dose of short-acting octrotide or short-acting dopamine agonists. In case of a single dose of short-acting octrotide, the dose should not be used to predict the response to the octretide treatment. The single dose of short-acting octreotide or short-acting dopamine agonists should not be administered in the 3 days prior to randomization
  • Patients with compression of the optic chiasm causing any visual field defect
  • Patients who have received pituitary irradiation within the last ten years prior to visit 1
  • Poorly controlled diabetic patients

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600886

  Hide Study Locations
Locations
United States, California
Cedars Sinai Medical Center The Pituitary Center
Los Angeles, California, United States, 90048
UCLA/ University of California Los Angeles Division of Endocrinology
Los Angeles, California, United States, 90095
Stanford University Medical Center Stanford Cancer Center (3)
Stanford, California, United States, 94304
United States, Florida
University of Florida SC
Gainesville, Florida, United States, 32610
United States, Maryland
Johns Hopkins University School of Medicine Dept.ofJohnsHopkinsUniv.
Baltimore, Maryland, United States, 21205
United States, Michigan
University of Michigan Comprehensive Cancer Center Deptof Endocrinology&Diabetes
Ann Arbor, Michigan, United States, 48109-0944
United States, New York
Columbia University Medical Center- New York Presbyterian Dept. of CU Collegeof Phys&Sur
New York, New York, United States, 10032
Northport VA Medical Center
Northport, New York, United States, 11768
United States, Oregon
Oregon Health & Sciences University DeptofOregonHealth&Sciences(3)
Portland, Oregon, United States, 97201
United States, Pennsylvania
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
University of Texas Southwestern Medical Center Danziger Research Bldg.
Dallas, Texas, United States, 75390-8527
Baylor College of Medicine
Houston, Texas, United States, 77030
MD Anderson Cancer Center/University of Texas Endocrine Neoplasia & Hormonal
Houston, Texas, United States, 77030-4009
United States, Washington
Swedish Medical Center Dept.ofSeattle Neuroscience(2)
Seattle, Washington, United States
Argentina
Novartis Investigative Site
Capital Federal, Buenos Aires, Argentina, 1425EKP
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Buenos Aires, Argentina, C1232AAC
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Buenos Aires, Argentina, C1405BCH
Belgium
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Bruxelles, Belgium, 1070
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Gent, Belgium, 9000
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Jette, Belgium, 1090
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Leuven, Belgium, 3000
Brazil
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Fortaleza, CE, Brazil, 60430-370
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Brasilia, DF, Brazil, 70840-901
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Sao Luis, MA, Brazil, 65020-070
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Curitiba, PR, Brazil, 80060-900
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Rio de Janeiro, RJ, Brazil, 21941-913
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São Paulo, SP, Brazil, 05403-000
Canada, Alberta
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Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y6
Canada, Quebec
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Montreal, Quebec, Canada, H2L 2W5
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Sherbrooke, Quebec, Canada, J1H 5N4
China
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Beijing, China, 100730
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Shanghai, China, 200025
Colombia
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Bogotá, Colombia, 00000
Czech Republic
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Prague 2, Czech Republic, 128 02
Denmark
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Aalborg, Denmark, DK-9100
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Copenhagen, Denmark, DK-2100
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Odense C, Denmark, DK-5000
France
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Bois Guillaume Cedex, France, 76233
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Bron Cedex, France, 69677
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Le Kremlin Bicetre, France, 94275
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Marseille cedex 05, France, 13385
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Montpellier Cedex 5, France, 34295
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Paris, France, 75006
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Pessac Cedex, France, 33604
Germany
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Berlin, Germany, 12200
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Berlin, Germany, 10098
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Erlangen, Germany, 91054
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Essen, Germany, 45122
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Muenchen, Germany, 80336
Greece
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Athens, Greece, GR 156 69
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Pireas, Greece, 18537
Hungary
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Budapest, Hungary, 1085
Israel
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Jerusalem, Israel, 91120
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Petach Tikva, Israel, 49100
Italy
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Cona, FE, Italy, 44100
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Genova, GE, Italy, 16132
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Padova, PD, Italy, 35128
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Roma, RM, Italy, 00168
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Torino, TO, Italy, 10126
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Napoli, Italy, 80131
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Pisa, Italy, 56124
Korea, Republic of
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Seoul, Korea, Korea, Republic of, 135-710
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Seoul, Korea, Korea, Republic of, 120-752
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Seoul, Korea, Republic of, 130-702
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Seoul, Korea, Republic of, 738-736
Mexico
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Mexico, Distrito Federal, Mexico, 06726
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México, Distrito Federal, Mexico, 06720
Netherlands
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Nijmegen, Netherlands, 6525 GA
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Rotterdam, Netherlands, 3015 CE
Norway
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Bergen, Norway, NO-5021
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Oslo, Norway, NO-0027
Poland
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Kraków, Poland, 31-501
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Warszawa, Poland, 01 809
Portugal
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Lisboa, Portugal, 1349-019
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Porto, Portugal, 4200-319
Russian Federation
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Moscow, Russian Federation, 119992
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Moscow, Russian Federation, 117036
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Saint-Petersburg, Russian Federation, 198013
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Saint-Petersburg, Russian Federation, 197341
Spain
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Sevilla, Andalucía, Spain, 41013
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Hospitalet de Llobregat, Cataluña, Spain, 08907
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Alicante, Comunidad Valenciana, Spain, 03010
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Santiago de Compostela, Galicia, Spain, 15706
Sweden
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Linkoping, Sweden, SE-581 85
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Malmö, Sweden, SE-205 02
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Uppsala, Sweden, SE-751 85
Switzerland
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St. Gallen, Switzerland, 9007
Taiwan
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Lin-Ko, Taiwan, 33305
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Taichung, Taiwan, 40705
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Taipei, Taiwan, 10002
Turkey
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Ankara, Turkey, 06100
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Erzurum, Turkey, 25240
United Kingdom
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Leeds, United Kingdom, LS1 3EX
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Liverpool, United Kingdom, L7 8XP
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London, United Kingdom, EC1A 7BE
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Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Chair: Novartis Novartis
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00600886     History of Changes
Other Study ID Numbers: CSOM230C2305, 2007-001972-36
Study First Received: January 14, 2008
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Australia: Department of Health
Belgium: Ministry of Social Affairs, Public Health and the Environment
Brazil: National Health Surveillance Agency
Canada: Food Inspection Agency
China: Ministry of Health
Colombia: Institutional Review Board
Czech Republic: Ministry of Health
Denmark: Ministry of Health
France: Ministry of Health
Greece: Ministry of Health and Welfare
Germany: Ministry of Health
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: Ministry of Health
Korea, Republic of: Food and Drug Administration
Mexico: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sports
Norway: Norwegian Medicines Agency
Poland: Ministry of Health and Social Security
Portugal: Ministry of Health
Russia: Ministry of Public health
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
Switzerland: Ethikkommission
Turkey: Ministry of Health
Taiwan: Department of Health
United Kingdom: Health Protection Agency
Venezuela: Ministry of Health and Social Development

Keywords provided by Novartis:
Acromegaly,
adult,
growth hormone,
insulin-like growth factor I,
somatostatin analogue

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014