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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00600886

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.

Condition	Intervention	Phase
Acromegaly	Drug: Pasireotide	Phase III

Drug Information available for: Insulin Insulin-like growth factor I Mecasermin rinfabate Octreotide Octreotide acetate Somatotropin Somatropin Somatostatin Pasireotide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly

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.

Secondary Outcome Measures:

compare the effect of Pasireotide LAR and Octreotide LAR on change from baseline in mean growth hormone at 12 months of treatment

Estimated Enrollment:	330
Study Start Date:	November 2007

Eligibility

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

Criteria

Inclusion criteria

Male or female patients aged at least 18 years.
Patients with active acromegaly.
Patients who have undergone a first surgery of the pituitary adenoma but are still medical treatment naïve.
de-novo patients who present with a visible 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.

Exclusion criteria

Patients who are being or were treated with octreotide, lanreotide, dopamine agonists or GH antagonists.
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 study start
Poorly controlled diabetic patients
Patients with symptomatic cholelithiasis

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

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

Contacts

Contact: Novartis U.S.	1800-340-6848
Contact: Novartis Basel	41 61 324 1111

Locations

United States, California
Stanford University Medical Center	Recruiting
Stanford, California, United States, 94305
Contact: Laurence Katznelson 650-723-3551
Principal Investigator: Laurence Katznelson, M.D.
David Geffen School of Medicine at UCLA	Recruiting
Los Angeles, California, United States
Contact: Anthony Heaney, M.D. 310-423-2411
Principal Investigator: Anthony Heaney, M.D.
Cedars-Sinai Medical Center	Recruiting
Los Angeles, California, United States, 90048
Contact: Shlomo Melmed, M.D. 310-423-2411
Principal Investigator: Shlomo Melmed, M.D.
United States, Florida
University of Florida Department of Medicine	Recruiting
Gainesville, Florida, United States, 32601
Contact: Laurence Kennedy, M.D. 352-392-2612
Principal Investigator: Laurence Kennedy, M.D
United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Beverly Biller, M.D. 617-726-7473
Principal Investigator: Beverly Biller, D.O.
United States, Michigan
University of Michigan	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Ariel Barkan, M.D. 734-936-5504
Principal Investigator: Ariel Barkan, M.D.
United States, New York
NYU	Not yet recruiting
New York, New York, United States, 10003
Contact: David Kleinberg, M.D. 212-263-4181
Principal Investigator: David Kleinberg, M.D.
Columbia University College of Physicians and Surgeons	Recruiting
NY, New York, United States
Contact: Pamela Freda, M.D. 212-305-4921
Principal Investigator: Pamela Freda, M.D.
United States, Oregon
Oregon Health and Sciences University	Recruiting
Portland, Oregon, United States, 97239
Contact: Maria Fleseriu, M.D. 503-494-9546
Principal Investigator: Maria Fleseriu, M.D.
United States, Texas
MD Anderson	Recruiting
Houston, Texas, United States, 77030
Contact: Stephen Waguespack, M.D. 713-792-2841
Principal Investigator: Stephen Waguespack, M.D.
United States, Washington
Swedish Medical Center	Recruiting
Seattle, Washington, United States, 98104
Contact: William Ludlum, M.D. 206-386-3878
Principal Investigator: William Ludlum, M.D.
Canada, British Columbia
Novartis Investigative Site	Recruiting
Vancouver, British Columbia, Canada
Contact: Joan Poon +1-604-263-3661
Principal Investigator: Ehud Ur, M.D.
Canada, Nova Scotia
Novartis Investigative Site	Recruiting
Halifax, Nova Scotia, Canada
Contact: Glenda McCarthy +1-902-473-7803
Principal Investigator: Ali Imran, M.D.
Canada, Quebec
Novartis Investigative Site	Recruiting
Montreal, Quebec, Canada
Contact: Claire Girard +1-514-890-8000 ext 28037
Principal Investigator: Omar Serri, M.D.
Novartis Investigative Site	Recruiting
Sherbrooke, Quebec, Canada
Contact: Line Larrivee +1-819-346-1110 ext 12889
Principal Investigator: Ghislaine Houde, M.D.

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	CSOM230C2305
Study First Received:	January 14, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00600886
Health Authority:	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; Czech Republic: Ministry of Health; Germany: Ministry of Health; Denmark: Ministry of Health; Spain: Ministry of Health and Consumption; France: Ministry of Health; United Kingdom: Health Protection Agency; Greece: Ministry of Health and Welfare; 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; Turkey: Ministry of Health; Taiwan: Department of Health; United States: Food and Drug Administration

Keywords provided by Novartis:

Acromegaly,
adult,
growth hormone,
insulin-like growth factor I,
somatostatin analogue

Study placed in the following topic categories:

Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Central Nervous System Diseases
Endocrine System Diseases
Octreotide
Brain Diseases

Bone Diseases
Insulin
Somatostatin
Musculoskeletal Diseases
Endocrinopathy
Acromegaly

Additional relevant MeSH terms:

Hyperpituitarism
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009