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:
Novartis Pharmaceuticals
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600886
Hide Study Locations
Hide Study LocationsLocations
| 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 | |
| Novartis Investigative Site | |
| Buenos Aires, Argentina, C1232AAC | |
| Novartis Investigative Site | |
| Buenos Aires, Argentina, C1405BCH | |
| Belgium | |
| Novartis Investigative Site | |
| Bruxelles, Belgium, 1070 | |
| Novartis Investigative Site | |
| Gent, Belgium, 9000 | |
| Novartis Investigative Site | |
| Jette, Belgium, 1090 | |
| Novartis Investigative Site | |
| Leuven, Belgium, 3000 | |
| Brazil | |
| Novartis Investigative Site | |
| Fortaleza, CE, Brazil, 60430-370 | |
| Novartis Investigative Site | |
| Brasilia, DF, Brazil, 70840-901 | |
| Novartis Investigative Site | |
| Sao Luis, MA, Brazil, 65020-070 | |
| Novartis Investigative Site | |
| Curitiba, PR, Brazil, 80060-900 | |
| Novartis Investigative Site | |
| Rio de Janeiro, RJ, Brazil, 21941-913 | |
| Novartis Investigative Site | |
| São Paulo, SP, Brazil, 05403-000 | |
| Canada, Alberta | |
| Novartis Investigative Site | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Canada, British Columbia | |
| Novartis Investigative Site | |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Canada, Nova Scotia | |
| Novartis Investigative Site | |
| Halifax, Nova Scotia, Canada, B3H 2Y6 | |
| Canada, Quebec | |
| Novartis Investigative Site | |
| Montreal, Quebec, Canada, H2L 2W5 | |
| Novartis Investigative Site | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| China | |
| Novartis Investigative Site | |
| Beijing, China, 100730 | |
| Novartis Investigative Site | |
| Shanghai, China, 200025 | |
| Colombia | |
| Novartis Investigative Site | |
| Bogotá, Colombia, 00000 | |
| Czech Republic | |
| Novartis Investigative Site | |
| Prague 2, Czech Republic, 128 02 | |
| Denmark | |
| Novartis Investigative Site | |
| Aalborg, Denmark, DK-9100 | |
| Novartis Investigative Site | |
| Copenhagen, Denmark, DK-2100 | |
| Novartis Investigative Site | |
| Odense C, Denmark, DK-5000 | |
| France | |
| Novartis Investigative Site | |
| Bois Guillaume Cedex, France, 76233 | |
| Novartis Investigative Site | |
| Bron Cedex, France, 69677 | |
| Novartis Investigative Site | |
| Le Kremlin Bicetre, France, 94275 | |
| Novartis Investigative Site | |
| Marseille cedex 05, France, 13385 | |
| Novartis Investigative Site | |
| Montpellier Cedex 5, France, 34295 | |
| Novartis Investigative Site | |
| Paris, France, 75006 | |
| Novartis Investigative Site | |
| Pessac Cedex, France, 33604 | |
| Germany | |
| Novartis Investigative Site | |
| Berlin, Germany, 12200 | |
| Novartis Investigative Site | |
| Berlin, Germany, 10098 | |
| Novartis Investigative Site | |
| Erlangen, Germany, 91054 | |
| Novartis Investigative Site | |
| Essen, Germany, 45122 | |
| Novartis Investigative Site | |
| Muenchen, Germany, 80336 | |
| Greece | |
| Novartis Investigative Site | |
| Athens, Greece, GR 156 69 | |
| Novartis Investigative Site | |
| Pireas, Greece, 18537 | |
| Hungary | |
| Novartis Investigative Site | |
| Budapest, Hungary, 1085 | |
| Israel | |
| Novartis Investigative Site | |
| Jerusalem, Israel, 91120 | |
| Novartis Investigative Site | |
| Petach Tikva, Israel, 49100 | |
| Italy | |
| Novartis Investigative Site | |
| Cona, FE, Italy, 44100 | |
| Novartis Investigative Site | |
| Genova, GE, Italy, 16132 | |
| Novartis Investigative Site | |
| Padova, PD, Italy, 35128 | |
| Novartis Investigative Site | |
| Roma, RM, Italy, 00168 | |
| Novartis Investigative Site | |
| Torino, TO, Italy, 10126 | |
| Novartis Investigative Site | |
| Napoli, Italy, 80131 | |
| Novartis Investigative Site | |
| Pisa, Italy, 56124 | |
| Korea, Republic of | |
| Novartis Investigative Site | |
| Seoul, Korea, Korea, Republic of, 135-710 | |
| Novartis Investigative Site | |
| Seoul, Korea, Korea, Republic of, 120-752 | |
| Novartis Investigative Site | |
| Seoul, Korea, Republic of, 130-702 | |
| Novartis Investigative Site | |
| Seoul, Korea, Republic of, 738-736 | |
| Mexico | |
| Novartis Investigative Site | |
| Mexico, Distrito Federal, Mexico, 06726 | |
| Novartis Investigative Site | |
| México, Distrito Federal, Mexico, 06720 | |
| Netherlands | |
| Novartis Investigative Site | |
| Nijmegen, Netherlands, 6525 GA | |
| Novartis Investigative Site | |
| Rotterdam, Netherlands, 3015 CE | |
| Norway | |
| Novartis Investigative Site | |
| Bergen, Norway, NO-5021 | |
| Novartis Investigative Site | |
| Oslo, Norway, NO-0027 | |
| Poland | |
| Novartis Investigative Site | |
| Kraków, Poland, 31-501 | |
| Novartis Investigative Site | |
| Warszawa, Poland, 01 809 | |
| Portugal | |
| Novartis Investigative Site | |
| Lisboa, Portugal, 1349-019 | |
| Novartis Investigative Site | |
| Porto, Portugal, 4200-319 | |
| Russian Federation | |
| Novartis Investigative Site | |
| Moscow, Russian Federation, 119992 | |
| Novartis Investigative Site | |
| Moscow, Russian Federation, 117036 | |
| Novartis Investigative Site | |
| Saint-Petersburg, Russian Federation, 198013 | |
| Novartis Investigative Site | |
| Saint-Petersburg, Russian Federation, 197341 | |
| Spain | |
| Novartis Investigative Site | |
| Sevilla, Andalucía, Spain, 41013 | |
| Novartis Investigative Site | |
| Hospitalet de Llobregat, Cataluña, Spain, 08907 | |
| Novartis Investigative Site | |
| Alicante, Comunidad Valenciana, Spain, 03010 | |
| Novartis Investigative Site | |
| Santiago de Compostela, Galicia, Spain, 15706 | |
| Sweden | |
| Novartis Investigative Site | |
| Linkoping, Sweden, SE-581 85 | |
| Novartis Investigative Site | |
| Malmö, Sweden, SE-205 02 | |
| Novartis Investigative Site | |
| Uppsala, Sweden, SE-751 85 | |
| Switzerland | |
| Novartis Investigative Site | |
| St. Gallen, Switzerland, 9007 | |
| Taiwan | |
| Novartis Investigative Site | |
| Lin-Ko, Taiwan, 33305 | |
| Novartis Investigative Site | |
| Taichung, Taiwan, 40705 | |
| Novartis Investigative Site | |
| Taipei, Taiwan, 10002 | |
| Turkey | |
| Novartis Investigative Site | |
| Ankara, Turkey, 06100 | |
| Novartis Investigative Site | |
| Erzurum, Turkey, 25240 | |
| United Kingdom | |
| Novartis Investigative Site | |
| Leeds, United Kingdom, LS1 3EX | |
| Novartis Investigative Site | |
| Liverpool, United Kingdom, L7 8XP | |
| Novartis Investigative Site | |
| London, United Kingdom, EC1A 7BE | |
| Novartis Investigative Site | |
| 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 Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 23, 2013