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

Phase 3

Completed

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

• Registration Number: NCT00444873
• Lead Sponsor: Ipsen

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2007-03-07
• Study First Submitted QC: 2007-03-07
• Study First Posted: 2007-03-08
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
28 day dose interval	lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval	-
42 day dose interval	lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval	-
56 day dose interval	lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval	-

Primary Outcome Measures

Name	Time	Method
Mean Insulin like Growth Factor 1 (IGF-1) and Growth Hormone (GH) levels at the beginning and end of the study and as proportion of patients conforming to internationally accepted levels.	1 dose interval after the last administration of Lanreotide Autogel 120mg

Secondary Outcome Measures

Name	Time	Method
Dose interval, 28, 42 or 56 days for repeated injections of Lanreotide Autogel 120mg which are effective in reducing IGF-1 and GH levels to internationally accepted levels.	Last three injections of Lanreotiude Autogel 120mg
Patient symptoms and quality of life on Lanreotide Autogel and comparison to previous Octreotide LAR treatment.	1 dose interval after the last administration of Lanreotide Autogel 120mg
Dose interval, 28, 42 or 56 days for repeated injections of Lanreotide Autogel 120mg, which shows comparable efficacy to the previous treatment with Octreotide LAR 10, 20 or 30 mg in controlling IGF-1 and GH levels	Interval between doses after titration in part 2 of treatment (injections 3-6)

Trial Locations

Locations (1)

Klinikum Innenstadt; 🇩🇪 Munich, Germany