Brief Title
Study to Evaluate Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG)
Official Title
A Pilot Study to Evaluate the Correlation Between Plasma Lanreotide Levels and GH/IGF-1 Dynamics and Clinical Improvement in Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG)
Brief Summary
The purpose of the protocol is to evaluate the correlation between plasma lanreotide levels and Growth Hormone (GH)/Insulin Like Growth Factor 1 (IGF-1) dynamics and clinical improvement in patients with acromegaly treated with lanreotide Autogel (Somatuline ATG)
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
GH (basal and during Oral Glucose Tolerance Test (OGTT)) and IGF-1 levels, in acromegalic patients previously treated with octreotide long acting release (LAR) 20 mg.
Secondary Outcome
Number of patients with GH levels ≤ 2.5 ng/mL and the number of patients with IGF-1 level < upper limit of normal (ULN).
Condition
Acromegaly
Intervention
lanreotide (Autogel formulation)
Study Arms / Comparison Groups
1
Description:
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
0
Start Date
May 2008
Completion Date
December 2008
Primary Completion Date
December 2008
Eligibility Criteria
Inclusion Criteria: - Patient on treatment with octreotide LAR 20 mg administered every 28 days for at least 3 months prior to visit 1. - Patient must have serum GH level ≤ 2.5 ng/mL and serum IGF-1 ≤ 1.3 ULN, 28 days after their last injection of octreotide LAR 20 mg at visit 1. - Patients must have serum GH level > 2.5 ng/mL AND serum IGF-1 level > 1.3 ULN, 6 or 8 weeks after their last injection of octreotide LAR 20 mg. Exclusion Criteria: - The patient has received pituitary radiation therapy of any kind at any time prior to visit 1. - The patient has received pituitary surgery within 3 months prior to visit 1. - The patient's serum creatinine is higher than 150 µmol/l.
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Ipsen Medical Director, ,
Location Countries
Mexico
Location Countries
Mexico
Administrative Informations
NCT ID
NCT00517491
Organization ID
A-38-52030-725
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical Director, Study Director, Ipsen
Verification Date
August 2019