Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg

Official Title

Optimisation of Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg

Brief Summary

      The study aims to evaluate the biochemical and clinical effectiveness on symptoms and tumor
      size of a monotherapy with Lanreotide 120mg in acromegalic subjects, to describe criteria for
      starting alternative strategies, and to describe the modalities and the global effectiveness
      of alternative strategies.

Study Type

Observational

Primary Outcome

Percentage of subjects who achieve a safe concentration of random Growth Hormone (GH) (≤2.5 ng/mL) and normal age and sex-matched Insulin-like Growth Factor-1 (IGF-1) concentration of the monotherapy phase.

Secondary Outcome

 Profile of subjects

Condition

Acromegaly

Publications

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

Recruitment Information

Estimated Enrollment

4

Start Date

January 2016

Completion Date

June 2016

Primary Completion Date

January 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Male or female aged 18 years or more, suffering from acromegaly

          -  Treatment naïve or treated subject (whatever the previous treatments except Lanreotide
             120mg and radiotherapy) who does not achieve biochemical control in the physician's
             opinion. Requiring a treatment with Somatostatin analog (SSA)

          -  Having performed a Magnetic Resonance Imaging (MRI) to evaluate the tumor size within
             the previous 12 weeks (post-surgery MRI for operated subjects)

          -  In whom the physician has already decided to initiate a treatment with Lanreotide
             120mg as a monotherapy

        Exclusion Criteria:

          -  Subject previously/currently treated with Lanreotide 120mg

          -  History of radiotherapy for acromegaly

          -  Subject who requires a surgical intervention for relief of any sign or symptom
             associated with tumor compression

          -  Concomitant prolactin hypersecretion requiring a treatment with dopaminergic agonists

          -  Active neoplastic disease

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

NCT02698384

Organization ID

A-54-52030-315

Responsible Party

Sponsor

Study Sponsor

Ipsen

Study Sponsor

Ipsen Medical Director, Study Director, Ipsen

Verification Date

December 2018