Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly

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Brief Title

Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly

Official Title

Phase III, Multicentre, Open Clinical Study on the Efficacy and Tolerability of a New Slow-release Formulation of Lanreotide (Autogel 120 mg) in Patients With Active Acromegaly

Brief Summary

      The purpose of the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the
      control of Growth Hormone (GH) secretion in patients with active acromegaly.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Growth hormone assessment

Secondary Outcome

 Insulin-like Growth Factor 1 (IGF-1) and Acid-Labile Subunit (ALS) assessments

Condition

Acromegaly

Intervention

lanreotide (Autogel formulation), duration of treatment 46-48 weeks

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

63

Start Date

January 2001

Completion Date

May 2003

Eligibility Criteria

        Inclusion Criteria:

          -  Documented diagnosis of active acromegaly, defined by serum GH levels above 5 µg/L,
             absence of reduction of serum GH levels below 1µg/L after oral glucose tolerance test
             (OGTT) and abnormal IGF-1 values

        Exclusion Criteria:

          -  Patients who have undergone pituitary surgery less than 3 months before selection

          -  Patients previously treated with radiotherapy

          -  Patients previously treated with somatostatin analogue except for a pre-surgical
             treatment not longer than 3 months

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ipsen Medical Director, ,

Location Countries

Italy

Location Countries

Italy

Administrative Informations

NCT ID

NCT00499993

Organization ID

A-93-52030-077

Responsible Party

Sponsor

Study Sponsor

Ipsen

Study Sponsor

Ipsen Medical Director, Study Director, Ipsen

Verification Date

January 2019