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

Acromegaly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225979
• Other study ID #: CSMS995B2402
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2005
• Last updated: April 10, 2012
• Start date: November 2002
• Est. completion date: March 2005

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• Octreotide LAR

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean GH and IGF-I at baseline, week 12, 24 and 48
Secondary	Tumor volume at baseline, week 24 and 48
Secondary	Signs and symptoms of acromegaly at baseline, week 12, 24 and 48
Secondary	Quality of life and sleep apnea at baseline, week 12, 24 and 48
Secondary	Safety and tolerability at any time on treatment