Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) in Acromegalic Subjects

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Acromegaly
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Brief Title

Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) in Acromegalic Subjects

Official Title

Observational, Multicenter, Cross-sectional, Observational Study to Evaluate the Effectiveness in Routine Clinical Practice of Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) for the Treatment of Acromegaly: SOMACROL Study.

Brief Summary

      The purpose of this study is to evaluate the effectiveness in IGF-1 control of lanreotide
      Autogel (ATG) 120 mg at extended dosing intervals (EDIs) (>4 weeks) in subjects with
      acromegaly in daily clinical practice.

Study Type

Observational

Primary Outcome

Percentage of subjects with a normal Insulin-like Growth Factor 1 (IGF-1) level in the assay before the study visit.

Secondary Outcome

 Percentage of subjects with Growth hormone (GH) levels ≤ 2.5 ng/mL or ≤ 1 ng/mL in the assay before the study visit.

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

115

Start Date

July 2016

Completion Date

September 2017

Primary Completion Date

September 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Men or women aged ≥ 18 years

          -  Diagnosed with acromegaly

          -  Receiving treatment with ATG 120 mg at extended dosing intervals (> 4 weeks) for at
             least six months before the study visit.

          -  Assay data (blood GH and IGF-1 levels) from immediately before the study visit
             (performed at least six months after starting the treatment) is available.

          -  Able to sign the informed consent form for study participation.

        Exclusion Criteria:

          -  Received radiation therapy treatment in the last six months.

          -  Active participation in another clinical study.

          -  Physical or mental disorders that, in the investigator's opinion, could affect their
             ability to sign the informed consent form.

          -  Pregnancy or breastfeeding for female patients.

          -  No data in their medical records on the treatment start date for ATG 120 mg at
             extended dosing intervals or on changes to the schedule of administration over the
             last six months.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ipsen Medical Director, ,

Location Countries

Portugal

Location Countries

Portugal

Administrative Informations

NCT ID

NCT02807233

Organization ID

A-ES-52030-352

Secondary IDs

IPS-SOM-2015-01

Responsible Party

Sponsor

Study Sponsor

Ipsen

Study Sponsor

Ipsen Medical Director, Study Director, Ipsen

Verification Date

August 2019