Octreotide Efficacy and Safety in First-Line Acromegalic Patients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2005

Last Updated Date

August 17, 2006

Start Date ^†

July 2002

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00171886 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Octreotide Efficacy and Safety in First-Line Acromegalic Patients

Official Title ^†

Octreotide Efficacy and Safety in First-Line Acromegalic Patients

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Acromegaly

Intervention ^†

Drug: Octreotide

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Suspended

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00171886

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

None

Investigators ^†

Study Chair:

Novartis

Information Provided By

Novartis

Verification Date

September 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.