Brief Title
Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg Prolonged Release (PR) in Acromegaly
Official Title
A Phase III, Prospective, Randomised, Open Label Study to Compare the Efficacy and Safety of Lanreotide Autogel® 60, 90 or 120 mg With Lanreotide 40 mg PR in Subjects With Active Acromegaly
Brief Summary
The purpose is to compare the efficacy and safety of lanreotide autogel® 60mg, 90mg or 120mg with lanreotide 40mg PR in subjects with active acromegaly.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Standardised Mean Change From Baseline in Age-adjusted IGF-1 Levels at the EOST/EW Visit
Secondary Outcome
Percentage of Subjects With Normal Age-adjusted IGF-1 Levels at the EOST/EW Visit
Condition
Acromegaly
Intervention
Lanreotide Autogel®
Study Arms / Comparison Groups
Lanreotide Autogel® 60mg, 90mg and 120mg
Description: Lanreotide Autogel 90mg from day 1 to week 13, 1 injection every 4 weeks (4 in total), titrated to 60mg, 90mg, or 120mg at week 17, then from week 17 to week 29 each group receives 1 injection every 4 weeks (4 in total/group).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
128
Start Date
October 2014
Completion Date
February 16, 2017
Primary Completion Date
November 2016
Eligibility Criteria
Inclusion Criteria: - Subject has active acromegaly defined as elevated GH and IGF-1 levels (measured at a central laboratory) as outlined below: - A serum level for IGF-1 ≥1.3 x upper limit of normal range (ULN) during the screening period (applicable to both treatment naïve subjects and subjects who have stopped treatment and undergone a washout period prior to Visit 1(Week -4). - Subjects must have mean serum GH concentration ≥2.5 μg/L in a GH cycle (5 samples taken at 0, 30, 60, 90 and 120 minutes) during the screening period. - The subject has undergone surgical removal of an adenoma for acromegaly at least 3 months prior to Screening, or is likely to require pituitary surgery in the future but not before completing at least 32 weeks of study treatment plus an additional follow up of 8 weeks for subjects taking part in the pharmacokinetics (PK) extension, or for whom pituitary surgery is not an option (due to contraindications, refusal etc.) and is therefore never likely to undergo pituitary surgery. Exclusion Criteria: - The subject has been treated with radiotherapy within 10 years prior to Screening. - The subject has been treated with lanreotide Autogel, lanreotide PR, pegvisomant, cabergoline or octreotide LAR within 3 months of Screening or octreotide immediate release (IR) or bromocriptin within 2 weeks of Screening. - The subject has a history of or currently presents with clinically significant ventricular or atrial dysrhythmias ≥Grade 2, using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. - The subject has uncontrolled diabetes (glycosylated haemoglobin (HbA1c) >8.5%).
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Ipsen Medical Director, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02493517
Organization ID
8-55-52030-289
Secondary IDs
CTR20140698
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical Director, Study Director, Ipsen
Verification Date
January 2019