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Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00225979
First received: September 23, 2005
Last updated: April 10, 2012
Last verified: April 2012
History of Changes
  Purpose

Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. The objective of this study is to assess the safety and efficacy of long-acting repeatable formulation of octreotide and to compare it to the safety and efficacy of surgery in patients with acromegaly who have not had any previous treatment for acromegaly.


Condition Intervention Phase
Acromegaly
 Drug: Octreotide LAR
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Mean GH and IGF-I at baseline, week 12, 24 and 48

Secondary Outcome Measures:
  • Tumor volume at baseline, week 24 and 48
  • Signs and symptoms of acromegaly at baseline, week 12, 24 and 48
  • Quality of life and sleep apnea at baseline, week 12, 24 and 48
  • Safety and tolerability at any time on treatment

Enrollment: 100
Study Start Date: November 2002
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SMS995 Drug: Octreotide LAR
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:

  • Newly diagnosed or previously untreated acromegalic patients
  • Lack of suppression of GH nadir to <1.0 µg/L, after oral administration of 75 g of glucose (OGTT)
  • IGF-I levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender)

Exclusion Criteria:

  • Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass
  • No evidence of pituitary adenoma on Magnetic Resonance Imaging (MRI)
  • Symptomatic cholelithiasis

Other protocol-defined exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00225979

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00225979     History of Changes
Other Study ID Numbers: CSMS995B2402
Study First Received: September 23, 2005
Last Updated: April 10, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Novartis:
Acromegaly
Untreated
Newly diagnosed
Octreotide LAR
Pituitary surgery

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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 22, 2013