Clinical trial NCT00171886: Octreotide Efficacy and Safety in First-line Acromegalic Patients
Official title: Octreotide Efficacy and Safety in First-line Acromegalic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acromegaly
Keywords: Acromegaly
Otreotide
Tumor reduction
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: To evaluate the ability of Sandostatin® LAR® to decrease GH and IGF-I levels in acromegaly patients with micro- or macroadenomas not previously treated
timeFrame: at baseline, weeks 12, 24, 48
measure: To evaluate efficacy of Sandostatin® LAR® to reduce the size of micro- or macroadenomas in acromegaly patients with micro- or macroadenomas not previous treated
timeFrame: at baseline, weeks 12, 24, 48
Secondary outcomes:
measure: To evaluate the effect of Sandostatin® LAR® on Health Related Quality of Life.
timeFrame: at baseline, weeks 12, 24, 48
measure: To evaluate the ability of Sandostatin® LAR® to relieve acromegaly signs and symptoms
timeFrame: at baseline, weeks 12, 24, 48
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Novartis Investigative site
city: Barcelona
country: Spain
facility: Novartis Investigative site
city: Burgos
country: Spain
facility: Novartis Investigative site
city: Cordoba
country: Spain
facility: Novartis Investigative site
city: Coruna
country: Spain
facility: Novartis Investigative site
city: Madrid
country: Spain
facility: Novartis Investigative site
city: Malaga
country: Spain
facility: Novartis Investigative site
city: Tarragona
country: Spain
facility: Novartis Investigative site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: