Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly

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Acromegaly
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Brief Title

Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly

Official Title

Phase II, Open, Randomised, Parallel Group, Noncomparative Multicentre Study to Assess the Efficacy and Safety of Repeated Subcutaneous (S.C.) Administration of Different Doses of BIM 23A760 in Acromegalic Patients

Brief Summary

      The purpose of this study is to assess the efficacy of repeated subcutaneous (under the skin)
      injections at different doses of BIM 23A760 on growth hormone and insulin-like growth
      factor-1 levels in patients with acromegaly after 6 months of treatment.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1

Secondary Outcome

 Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1

Condition

Acromegaly

Intervention

BIM 23A760

Study Arms / Comparison Groups

 BIM 23A760 1 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

109

Start Date

October 2009

Completion Date

February 2011

Primary Completion Date

February 2011

Eligibility Criteria

        Inclusion Criteria:

          -  IGF-1 ≥1.3 x upper limit normal (ULN)

          -  Nadir serum GH concentration ≥0.4 ng/mL in an oral glucose tolerance test (OGTT)

          -  Patient must have documentation supporting the diagnosis of acromegaly, including
             elevated GH and/or insulin-like growth factor-1 (IGF-1) levels.

        Exclusion Criteria:

          -  The patient has received long acting somatostatin analogues within 6 months of study
             entry

          -  The patient has undergone radiotherapy at any time prior to study entry

          -  The time between pituitary surgery (if any) and study entry is less than 6 weeks

          -  The patient suffers from macroadenoma with visual field defects due to chiasmatic
             compression

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Ipsen Medical Director, ,

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations

NCT ID

NCT00994214

Organization ID

2-55-52060-003

Secondary IDs

2009-010787-42

Responsible Party

Sponsor

Study Sponsor

Ipsen

Study Sponsor

Ipsen Medical Director, Study Director, Ipsen

Verification Date

November 2019