Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients

Official Title

Phase III, Multicentre, Open Study to Assess the Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Previously Treated or Not by Somatostatin Analogues.

Brief Summary

      To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel
      given in doses titrated to effect in acromegalic patients previously treated or not with
      somatostatin analogues.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48)

Secondary Outcome

 Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range

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

63

Start Date

September 2000

Completion Date

July 15, 2002

Primary Completion Date

July 15, 2002

Eligibility Criteria

        Inclusion Criteria:

          -  Patient having documentation supporting diagnosis of active acromegaly in one of the
             following definitions:

               -  patient having received neither somatostatin analogue nor dopaminergic agonist
                  within the previous 12 weeks and having an IGF-1 level at least 1.3 times the
                  upper limit of the age-adjusted normal range,

               -  patient being treated with a somatostatin analogue (other than lanreotide
                  autogel) or a dopaminergic agonist when attending the first visit and having at
                  the end of the wash-out period an IGF-1 level at least 1.3 times the upper limit
                  of the age-adjusted normal range.

        Exclusion Criteria:

          -  Patient having had pituitary surgery within the previous 3 months

          -  Patient having received radiotherapy for acromegaly disease within the previous 36
             months

          -  Patient being predicted to require pituitary surgery (adenomectomy) or receive
             radiotherapy during the study period

          -  Patient having received lanreotide autogel at any time before the study

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ipsen Medical Director, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT00210457

Organization ID

E-54-52030-081

Responsible Party

Sponsor

Study Sponsor

Ipsen

Study Sponsor

Ipsen Medical Director, Study Director, Ipsen

Verification Date

March 2020