Study to Evaluate Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG)

Phase 2

Withdrawn

• Conditions: Acromegaly
• Interventions: Drug: lanreotide (Autogel formulation)

• Registration Number: NCT00517491
• Lead Sponsor: Ipsen

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-16
• Study First Submitted QC: 2007-08-16
• Study First Posted: 2007-08-17
• Study Start: 2008-05
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	lanreotide (Autogel formulation)	-

Primary Outcome Measures

Name	Time	Method
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.	Weeks 16, 18 & 20
Indices of insulin secretion & sensitivity	Weeks 16, 18 & 20
Adverse events	Throughout study
Acromegaly symptoms.	Weeks 16, 18 & 20

Secondary Outcome Measures

Name	Time	Method
ECG and gallbladder ultrasound	Week 20
Serum lanreotide Autogel 120 mg concentrations.	Weeks 16, 18 & 20.
Number of patients with GH levels ≤ 2.5 ng/mL and the number of patients with IGF-1 level < upper limit of normal (ULN).	Weeks 16, 18 & 20.

Trial Locations

Locations (1)

Centro Médico Nacional Siglo XXI, IMSS; 🇲🇽 Mexico City, Mexico