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Octreotide Efficacy and Safety in First-line Acromegalic Patients

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171886
First received: September 13, 2005
Last updated: March 23, 2011
Last verified: March 2011

September 13, 2005
March 23, 2011
July 2002
May 2006   (final data collection date for primary 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 [ Time Frame: at baseline, weeks 12, 24, 48 ] [ Designated as safety issue: No ]
  • To evaluate efficacy of Sandostatin® LAR® to reduce the size of micro- or macroadenomas in acromegaly patients with micro- or macroadenomas not previous treated [ Time Frame: at baseline, weeks 12, 24, 48 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00171886 on ClinicalTrials.gov Archive Site
  • To evaluate the effect of Sandostatin® LAR® on Health Related Quality of Life. [ Time Frame: at baseline, weeks 12, 24, 48 ] [ Designated as safety issue: Yes ]
  • To evaluate the ability of Sandostatin® LAR® to relieve acromegaly signs and symptoms [ Time Frame: at baseline, weeks 12, 24, 48 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Octreotide Efficacy and Safety in First-line Acromegalic Patients
Octreotide Efficacy and Safety in First-line Acromegalic Patients

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acromegaly
Drug: Octreotide
Other Name: SMS995
Experimental: octrotide
Intervention: Drug: Octreotide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
20
Not Provided
May 2006   (final data collection date for primary outcome measure)

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.

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00171886
CSMS995BES02
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP