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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Acromegaly

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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28 day dose interval

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.

42 day dose interval

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.

56 day dose interval

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.

Interventions

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

Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No