Octreotide Efficacy and Safety in First-line Acromegalic Patients

This study has suspended participant recruitment.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00171886

First received: September 13, 2005

Last updated: March 23, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

March 23, 2011

Start Date ^ICMJE

July 2002

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate the ability of Sandostatin® LAR® to decrease GH and IGF-I levels in acromegaly patients with micro- or macroadenomas not previously treated [ Time Frame: at baseline, weeks 12, 24, 48 ] [ Designated as safety issue: No ]
To evaluate efficacy of Sandostatin® LAR® to reduce the size of micro- or macroadenomas in acromegaly patients with micro- or macroadenomas not previous treated [ Time Frame: at baseline, weeks 12, 24, 48 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

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

Current Secondary Outcome Measures ^ICMJE

To evaluate the effect of Sandostatin® LAR® on Health Related Quality of Life. [ Time Frame: at baseline, weeks 12, 24, 48 ] [ Designated as safety issue: Yes ]
To evaluate the ability of Sandostatin® LAR® to relieve acromegaly signs and symptoms [ Time Frame: at baseline, weeks 12, 24, 48 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Octreotide Efficacy and Safety in First-line Acromegalic Patients

Official Title ^ICMJE

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Acromegaly

Intervention ^ICMJE

Drug: Octreotide

Other Name: SMS995

Study Arm (s)

Experimental: octrotide

Intervention: Drug: Octreotide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT00171886

Other Study ID Numbers ^ICMJE

CSMS995BES02

Has Data Monitoring Committee

Not Provided

Responsible Party

External Affairs, Novartis Pharmaceuticals

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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