Status:
COMPLETED
Octreotide Efficacy and Safety in First-line Acromegalic Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Acromegaly
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00171886
Start Date
July 1 2002
End Date
May 1 2006
Last Update
February 24 2017
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative site
A Coruña, Spain
2
Novartis Investigative site
Alicante, Spain
3
Novartis Investigative site
Barcelona, Spain
4
Novartis Investigative site
Burgos, Spain