Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

Official Title

A Phase IV, Open-label, Single Group Study to Evaluate the Dosing, Efficacy and Safety of Lanreotide Autogel® in Patients With Acromegaly Previously Treated With Octreotide LAR

Brief Summary

      The purpose of this study is to assess the efficacy, safety and patient acceptability of
      Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit.

Secondary Outcome

 The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit.

Condition

Acromegaly

Intervention

Lanreotide (Autogel formulation)

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

8

Start Date

June 2004

Completion Date

June 22, 2006

Primary Completion Date

June 22, 2006

Eligibility Criteria

        Inclusion Criteria:

          -  Clinical diagnosis of acromegaly

          -  The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and
             shown to have a GH level <10 mU/L.

          -  The patient must have been treated with a stable dose of octreotide LAR for at least
             four months prior to study entry

          -  Life expectancy of at least 2 years

        Exclusion Criteria:

          -  Adenectomy within past 6 months, or likely during study period

          -  Radiotherapy for acromegalic disease within 1 year, or likely during study period

          -  Unstable concomitant dopamine agonist therapy

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ipsen Study Director, ,

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT00216398

Organization ID

A-9B-52030-159

Responsible Party

Sponsor

Study Sponsor

Ipsen

Study Sponsor

Ipsen Study Director, Study Director, Ipsen

Verification Date

August 2019