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

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

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

Official Title

A Pilot Study to Evaluate the Correlation Between Plasma Lanreotide Levels and GH/IGF-1 Dynamics and Clinical Improvement in Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG)

Brief 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)

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

GH (basal and during Oral Glucose Tolerance Test (OGTT)) and IGF-1 levels, in acromegalic patients previously treated with octreotide long acting release (LAR) 20 mg.

Secondary Outcome

 Number of patients with GH levels ≤ 2.5 ng/mL and the number of patients with IGF-1 level < upper limit of normal (ULN).

Condition

Acromegaly

Intervention

lanreotide (Autogel formulation)

Study Arms / Comparison Groups

 1
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

0

Start Date

May 2008

Completion Date

December 2008

Primary Completion Date

December 2008

Eligibility 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.

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Ipsen Medical Director, ,

Location Countries

Mexico

Location Countries

Mexico

Administrative Informations

NCT ID

NCT00517491

Organization ID

A-38-52030-725

Responsible Party

Sponsor

Study Sponsor

Ipsen

Study Sponsor

Ipsen Medical Director, Study Director, Ipsen

Verification Date

August 2019