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

• Status: Withdrawn
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Angiopeptin; Lanreotide; Somatostatin

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.