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

Sponsor:	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 Drug: Octreotide	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), 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

Resource links provided by NLM:

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:

Compare effect of pasireotide LAR and octreotide LAR on tumor volume at 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
Compare the 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 ]
Assess 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 ]
Assess 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 ]

Estimated Enrollment:	330
Study Start Date:	February 2008
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
SOM230 LAR @ 40mg: Experimental SOM230 LAR @ 40mg	Drug: Pasireotide SOM230 LAR
Octreotide LAR @ 20 mg: Active Comparator Octreotide LAR @ 20 mg	Drug: Octreotide Sandostatin LAR

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 one or more pituitary surgeries, but have not been treated medically.
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

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 Pharmaceuticals ( External Affairs )
Study ID Numbers:	CSOM230C2305
Study First Received:	January 14, 2008
Last Updated:	December 8, 2009
ClinicalTrials.gov Identifier:	NCT00600886 History of Changes
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:

Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Nervous System Diseases
Gastrointestinal Agents
Central Nervous System Diseases
Endocrine System Diseases

Octreotide
Brain Diseases
Bone Diseases
Pharmacologic Actions
Hyperpituitarism
Musculoskeletal Diseases
Therapeutic Uses
Acromegaly

ClinicalTrials.gov processed this record on February 08, 2010