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

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

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-12-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Acromegaly

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

lanreotide (Autogel formulation)

Intervention Type DRUG

120 mg administered every 28 days via deep subcutaneous injection. A total of 4 injections will be administered during the study.

Interventions

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lanreotide (Autogel formulation)

120 mg administered every 28 days via deep subcutaneous injection. A total of 4 injections will be administered during the study.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No