Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects

Official Title

A Prospective, International, Multi-centric, Open-label Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel 120 mg in Acromegalic Subjects Who Are Biochemically Controlled on the Long Term Treatment With Octreotide LAR 10 or 20 mg

Brief Summary

      The purpose of the study is to assess the efficacy of an extended injection interval schedule
      of lanreotide Autogel 120 mg in acromegalic subjects who are biochemically controlled on long
      term treatment with octreotide LAR 10 or 20 mg

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted)

Secondary Outcome

 Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)

Condition

Acromegaly

Intervention

Lanreotide Autogel 120 mg

Study Arms / Comparison Groups

 Lanreotide Autogel 120 mg
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

124

Start Date

October 2008

Completion Date

May 2013

Primary Completion Date

March 2013

Eligibility Criteria

        Inclusion Criteria:

          -  The subject has given written informed consent prior to any study-related procedures

          -  The subject is male or female and is over 18 years of age

          -  The subject must have had documentation supporting the diagnosis of acromegaly, based
             on elevated IGF-1 and/or GH levels

          -  The subject has been receiving octreotide LAR (10 or 20 mg) treatment for at least six
             months and is biochemically controlled. Control is defined as normal (age and sex
             adjusted) IGF 1 levels for two consecutive measurements (at least two months apart)
             preceding study entry

          -  If the subject is receiving dopamine agonist therapy, treatment should be stable for
             at least four months, and no change in their dopamine-agonist medication is expected
             during the entire study period

        Exclusion Criteria:

          -  The subject has received radiation therapy to the pituitary gland before study entry

          -  The subject has a history of hypersensitivity to lanreotide or drugs with a similar
             chemical structure

          -  The subject has received a growth hormone receptor antagonist (pegvisomant) therapy
             within three months before study entry

          -  The subject has undergone treatment with any other investigational drug in the 30 days
             before study entry or is scheduled to receive an investigational drug, other than
             lanreotide 120 mg, during the course of the study

          -  The subject has received any unlicensed drug within the 30 days prior to the baseline
             visit or is scheduled to receive an unlicensed drug during the course of the study

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ipsen Medical Director, ,

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations

NCT ID

NCT00701363

Organization ID

A-38-52030-214

Secondary IDs

2007-005838-37

Responsible Party

Sponsor

Study Sponsor

Ipsen

Study Sponsor

Ipsen Medical Director, Study Director, Ipsen

Verification Date

January 2019