Safety and Efficacy of Long-Acting Repeatable Octreotide Acetate for Injectable Suspension Vs. Surgery in Treatment-naïve Patients With Acromegaly

This study has been completed.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00225979

Purpose

Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. The objective of this study is to assess the safety and efficacy of long-acting repeatable formulation of octreotide and to compare it to the safety and efficacy of surgery in patients with acromegaly who have not had any previous treatment for acromegaly.

Condition	Intervention	Phase
Acromegaly	Drug: Octreotide LAR – pituitary surgery	Phase III

Drug Information available for: Octreotide Octreotide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of Long-Acting Repeatable Octreotide Acetate for Injectable Suspension Vs. Surgery in Treatment-naïve Patients With Acromegaly

Further study details as provided by Novartis:

Primary Outcome Measures:

Mean GH and IGF-I at baseline, week 12, 24 and 48

Secondary Outcome Measures:

Tumor volume at baseline, week 24 and 48
Signs and symptoms of acromegaly at baseline, week 12, 24 and 48
Quality of life and sleep apnea at baseline, week 12, 24 and 48
Safety and tolerability at any time on treatment

Estimated Enrollment:	100
Study Start Date:	November 2002

Eligibility

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

Criteria

Inclusion Criteria

Newly diagnosed or previously untreated acromegalic patients
Lack of suppression of GH nadir to <1.0 µg/L, after oral administration of 75 g of glucose (OGTT)
IGF-I levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender)

Exclusion Criteria

Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass
No evidence of pituitary adenoma on Magnetic Resonance Imaging (MRI)
Symptomatic cholelithiasis

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225979

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CSMS995B2402
Study First Received:	September 23, 2005
Last Updated:	September 21, 2006
ClinicalTrials.gov Identifier:	NCT00225979
Health Authority:	Italy: Ministry of Health

Keywords provided by Novartis:

Acromegaly
Untreated
Newly diagnosed
Octreotide LAR
Pituitary surgery

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