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
  Purpose

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.


Condition Intervention Phase
Acromegaly
Drug: Octreotide
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Octreotide Efficacy and Safety in First-line Acromegalic Patients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: July 2002
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: octrotide Drug: Octreotide
Other Name: SMS995

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171886

Locations
Spain
Novartis Investigative site
Alicante, Spain
Novartis Investigative site
Barcelona, Spain
Novartis Investigative site
Burgos, Spain
Novartis Investigative site
Cordoba, Spain
Novartis Investigative site
Coruna, Spain
Novartis Investigative site
Madrid, Spain
Novartis Investigative site
Malaga, Spain
Novartis Investigative site
Tarragona, Spain
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00171886     History of Changes
Other Study ID Numbers: CSMS995BES02
Study First Received: September 13, 2005
Last Updated: March 23, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Novartis:
Acromegaly
Otreotide
Tumor reduction

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014