Study Assessing the Efficacy and Safety of Octreotide Acetate in Patients With Acromegaly, With Micro or Macroadenomas

NCT00242541 | Terminated Phase 4

• 1 other identifier: CSMS995BMX02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of octreotide acetate to decrease GH and IGF-I levels in acromegalic patients, with microadenomas (≤ 10 mm) or macroadenomas (\> 10 mm).

Conditions

Acromegaly

Keywords

microadenoma; macroadenoma

Outcome Measures

Primary Outcomes (1)

• To evaluate the use of octreotide acetate to reduce levels of GH and IGF-I in Acromegalic patients with micro (< 10 mm) and macroadenomas (> 10 mm)

Secondary Outcomes (3)

• Safety and tolerability of multiple doses

• The efect of octreotide acetate in the tumor efect

• To evaluate the capability to reduce sign and symptoms of Acromegaly

Study Arms (1)

Octreotide acetate

EXPERIMENTAL

Drug: Octreotide acetate

Interventions

Octreotide acetate DRUG

Also known as: SMS995

Octreotide acetate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 18 - 80 years.
• Newly diagnosed or previously treated acromegalic patients.
• Lack of suppression of GH nadir to \<1.0 microg/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).

You may not qualify if:

• 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.
• Unstable angina, sustained ventricular tachycardia, ventricular fibrillation, or a history of acute myocardial infarction within the three months preceding study entry.
• Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or persistent ALT, AST, alkaline phosphatase 2 x \> upper limit of normal, or total bilirubin 1.5 x \> upper limit of normal.
• Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method for birth control. Medically acceptable methods include oral birth control pills, intrauterine devices, or mechanical methods (e.g. vaginal diaphragm, vaginal sponge or condom with spermicidal jelly). If oral contraception is used, the patient must have been practicing this method for at least two months prior to the screening visit and must agree to continue the oral contraceptive throughout the course of the study, and for one month after the study has ended.
• History of immunocompromise, including a positive HIV test result (ELISA and Western blot).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Mexico City, Mexico

Location

MeSH Terms

Conditions

Acromegaly

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2005
• First Posted: October 20, 2005
• Study Start: March 1, 2003
• Primary Completion: August 1, 2005
• Last Updated: April 26, 2012

Record last verified: 2012-04

Locations

ME (1)