Clinical Trial: Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase IV, Multicentre, Open-Label, Single Group Study to Evaluate the Dosing, Efficacy and Safety of Lanreotide Autogel in Patients With Acromegaly Previously Treated Wi

Brief Summary: The purpose of this study is to assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.

Detailed Summary:
Sponsor: Ipsen

Current Primary Outcome: The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit.
  • The percentage of patients with normalised IGF-1 compared to the baseline visit.
  • Change in the GH values compared to the baseline (Week 0) visit.
  • Change in the IGF-1 values compared to the baseline (Week 0) visit.
  • Change in serum lanreotide levels compared to the baseline (Week 0) visit.
  • Change in the serum octreotide levels compared to the baseline visit.
  • Patient evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.
  • Investigator evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment.


Original Secondary Outcome: Same as current

Information By: Ipsen

Dates:
Date Received: September 13, 2005
Date Started: June 2004
Date Completion: December 2006
Last Updated: October 11, 2007
Last Verified: October 2007