Octreotide Efficacy and Safety in First-line Acromegalic Patients

Brief Title

Octreotide Efficacy and Safety in First-line Acromegalic Patients

Official Title

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.
    

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

To evaluate the ability of Sandostatin® LAR® to decrease GH and IGF-I levels in acromegaly patients with micro- or macroadenomas not previously treated

Secondary Outcome

 To evaluate the effect of Sandostatin® LAR® on Health Related Quality of Life.

Condition

Acromegaly

Intervention

Octreotide

Study Arms / Comparison Groups

 octrotide

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

20

Start Date

July 2002

Completion Date

May 2006

Primary Completion Date

May 2006

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.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Novartis Pharmaceuticals, , 

Location Countries

Spain

Location Countries

Spain

NCT ID

NCT00171886

Organization ID

CSMS995BES02

Study Sponsor

Novartis Pharmaceuticals

Study Sponsor

Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

Verification Date

March 2011