Octreotide Efficacy and Safety in First-line Acromegalic Patients

Acromegaly Clinical Trial

Official title:

Octreotide Efficacy and Safety in First-line Acromegalic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00171886
• Other study ID #: CSMS995BES02
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: February 23, 2017
• Start date: July 2002
• Est. completion date: May 2006

Study information

• Verified date: March 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• Octreotide

Locations

Country	Name	City	State
Spain	Novartis Investigative site	Alicante
Spain	Novartis Investigative site	Barcelona
Spain	Novartis Investigative site	Burgos
Spain	Novartis Investigative site	Cordoba
Spain	Novartis Investigative site	Coruna
Spain	Novartis Investigative site	Madrid
Spain	Novartis Investigative site	Malaga
Spain	Novartis Investigative site	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the ability of Sandostatin® LAR® to decrease GH and IGF-I levels in acromegaly patients with micro- or macroadenomas not previously treated		at baseline, weeks 12, 24, 48
Primary	To evaluate efficacy of Sandostatin® LAR® to reduce the size of micro- or macroadenomas in acromegaly patients with micro- or macroadenomas not previous treated		at baseline, weeks 12, 24, 48
Secondary	To evaluate the effect of Sandostatin® LAR® on Health Related Quality of Life.		at baseline, weeks 12, 24, 48
Secondary	To evaluate the ability of Sandostatin® LAR® to relieve acromegaly signs and symptoms		at baseline, weeks 12, 24, 48