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Trial · Interventional

CompletedPhase 4Registry data

Octreotide Efficacy and Safety in First-line Acromegalic Patients

NCTNCT00171886 (opens ClinicalTrials.gov in a new tab)Other idCSMS995BES02
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Overview

Status
Completed
Phase
Phase 4
Enrollment
20 participants (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

Spain

Start
Jul 2002
Primary completion
May 2006
Completion
May 2006
First posted
15 Sept 2005 (estimated)
Last update posted
24 Feb 2017
Conditions
Acromegaly

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200220032004200520062007
  1. Ph 4

    Octreotide Efficacy and Safety in First-line Acromegalic Patients

    NCT00171886

    Jul 2002 to May 2006

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OctreotideDrug

Arms1

  • Experimental

    octrotide

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. 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

  2. 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

Secondary outcomes(2)

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

    Time frame · at baseline, weeks 12, 24, 48

  2. To evaluate the ability of Sandostatin® LAR® to relieve acromegaly signs and symptoms

    Time frame · at baseline, weeks 12, 24, 48

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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