Effect of 120mg Somatuline Autogel at Different Dose Intervals (28, 42 or 56 Days) in Patients With Acromegaly

Ipsen

Status and phase: Completed; Phase 3

Conditions: Acromegaly

Treatments: Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval

Study type: Interventional

Funder types: Industry

Identifiers

NCT00444873

2004-001435-33 (EudraCT Number)

A-94-52030-163

Details and patient eligibility

About

A multicentre, prospective, open label study of acromegalic patients evaluating the efficacy and safety of different dose-intervals of Lanreotide Autogel 120mg according to international standards and compared to previous treatment with Octreotide LAR 10, 20 or 30 mg.

Full description

Six repeated applications of Lanreotide Autogel 120mg administered every 28, 42 or 56 days. For the first three injections, the interval depends on the Octreotide LAR dosage administered previously. The dose interval is titrated after injection 3 depending on the efficacy of the therapy with Lanreotide Autogel

Enrollment: 38 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient must give written (personally signed and dated) informed consent before completing any study-related procedure.
• The patient must have a documented diagnosis of active acromegaly and be adequately treated with a stable dose (10, 20 or 30 mg) of Octreotide LAR for at least 6 months immediately prior to study entry. A documented diagnosis of active acromegaly is defined as IGF-1 more than 30% higher than two Standard Deviations ( +2 SD) above the normal age and sex adjusted value (see Appendix 6) or GH level after OGTT (Oral Glucose Tolerance Test) > 2ng/mL while not under drug treatment for acromegaly. For patients having undergone surgery or radiotherapy, this diagnosis must have been performed after the most recent surgical or radiation treatment

Exclusion criteria

• The patient has had pituitary surgery (adenomectomy) within 6 months prior to study entry
• The patient has received stereotactic (LINAC, Gamma Knife) radiotherapy for acromegaly within three years or conventional radiotherapy for acromegaly within five years prior to study entry

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 3 patient groups

28 day dose interval

Experimental group

Treatment:

Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval

42 day dose interval

Experimental group

Treatment:

Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval

56 day dose interval

Experimental group

Treatment:

Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval