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

Sponsor:	Novartis Pharmaceuticals
Information provided by (Responsible Party):	Novartis ( Novartis Pharmaceuticals )
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.

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 III

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:

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Octreotide acetate Octreotide Pasireotide

U.S. FDA Resources

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:	358
Study Start Date:	February 2008
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

Show 118 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Chair:

Novartis

More Information

Additional Information:

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00600886 History of Changes
Other Study ID Numbers:	CSOM230C2305, EudraCT number: 2007-001972-36
Study First Received:	January 14, 2008
Last Updated:	September 19, 2011
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; 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; United States: Food and Drug Administration; 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 February 09, 2012