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

Acromegaly Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00517491
• Other study ID #: A-38-52030-725
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 2008
• Est. completion date: December 2008

Study information

• Verified date: August 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• lanreotide (Autogel formulation)
120 mg administered every 28 days via deep subcutaneous injection. A total of 4 injections will be administered during the study.

Locations

Country	Name	City	State
Mexico	Centro Médico Nacional Siglo XXI, IMSS	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Acromegaly symptoms.		Weeks 16, 18 & 20
Primary	Indices of insulin secretion & sensitivity		Weeks 16, 18 & 20
Primary	Adverse events		Throughout study
Secondary	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.
Secondary	Serum lanreotide Autogel 120 mg concentrations.		Weeks 16, 18 & 20.
Secondary	ECG and gallbladder ultrasound		Week 20