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

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	Novartis

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	CSOM230C2305
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 October 28, 2008

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