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Octreotide Efficacy and Safety in First-line Acromegalic Patients

Phase 4
18 Years
80 Years
Not Enrolling

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Trial Information

Octreotide Efficacy and Safety in First-line Acromegalic Patients

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.

Type of Study:


Study Design:

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

Outcome 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

Outcome Time Frame:

at baseline, weeks 12, 24, 48

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

July 2002

Completion Date:

Related Keywords:

  • Acromegaly
  • Acromegaly
  • Otreotide
  • Tumor reduction
  • Acromegaly