Octreotide Efficacy and Safety in First-Line Acromegalic Patients - Full Text View

Sponsors and Collaborators:	Novartis None
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171886

Purpose

Primary Acromegaly is a clinical and metabolic disease caused by growth hormone (GH) hypersecretion from a pituitary adenoma and is an insidious, chronic disease that is associated with bony and soft tissue overgrowth. Goals of therapy are to eradicate the tumor, suppress GH secretion, normalize IGF-I levels, and preserve normal pituitary function.

This study will evaluate the safety and efficacy of octreotide as primary therapy for the treatment of acromegaly and as therapy for patients with acromegaly and a pituitary macroadenoma or microadenoma.

Condition	Intervention	Phase
Acromegaly	Drug: Octreotide	Phase IV

Drug Information available for: Octreotide Octreotide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Octreotide Efficacy and Safety in First-Line Acromegalic Patients

Further study details as provided by Novartis:

Study Start Date:

July 2002

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Males and females 18 and < 80 years old.
Recently diagnosed not previously treated patients with acromegaly.
Presence of a pituitary tumor (microadenoma or macroadenoma), documented by a MNR performed in the 12 weeks before enrolment.
Absence of nadir suppression of the nadir of GH to < 1.0 ng/mL, after oral administration of 75 g of glucose (OTTG).
IGF-I levels over normal upper limits, e.g. 97 percentile (age- and sex-matched).
Tolerance shown with a test of a subcutaneous injection of octreotide
Written Informed Consent before any procedure specific to the study. Inclus

Exclusion Criteria

Previously treated patients with any therapy for acromegaly, including surgery, radiotherapy, bromocriptin, and somatostatin analogues.
Compression of optic chiasm that produces any impairment of field of vision.
Need of surgery to improve any neurological sign or symptom associated with a direct incidence on the tumour.
Intolerance to octreotide or to any component of Sandostatin® LAR® preparation.
Patients with an hepatic condition such as cirrhosis, active or persisting chronic hepatitis, or other hepatopathy of fast evolution.
Pregnant women
History of alcohol or drug abuse in the six months prior to the inclusion visit.
Patients suffering from any condition that may jeopardize the interpretation of study results or may impede to obtain informed consent
Intake of an investigational drug during the study and 30 days before patient inclusion in this study

Other protocol-defined inclusion / exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171886

Sponsors and Collaborators

Novartis

None

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CSMS995BES02
Study First Received:	September 13, 2005
Last Updated:	August 17, 2006
ClinicalTrials.gov Identifier:	NCT00171886
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Novartis:

Acromegaly
Otreotide
Tumor reduction

Study placed in the following topic categories:

Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Musculoskeletal Diseases
Octreotide
Endocrine System Diseases

Central Nervous System Diseases
Endocrinopathy
Brain Diseases
Bone Diseases
Acromegaly

Additional relevant MeSH terms:

Hyperpituitarism
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

Nervous System Diseases
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009