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