Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly

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Brief Title

Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly

Official Title

Phase II, Multicentre, Randomized, Double-blind Study in Acromegalic Patients Evaluating the Efficacy and Safety of a Single Deep Subcutaneous Administration of Lanreotide Autogel (60, 90 or 120mg) Versus Placebo Followed by a Single Blind Fixed Dose Phase Evaluating the Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Profile of Multiple Deep Subcutaneous Administrations of Lanreotide Autogel (60, 90 & 120mg) Ending in Open Label Dose Titration Phase.

Brief Summary

      The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo
      after a single injection. Effectiveness and safety were then also assessed following four
      fixed-dose injections and after one year of treatment given at titrated doses.

Study Phase

Phase 2/Phase 3

Study Type

Interventional

Primary Outcome

Mean serum GH levels determined from serial measurements at screening, weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal

Secondary Outcome

 Serum IGF-1 levels determined at screening, at weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal

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

108

Start Date

May 2000

Completion Date

January 3, 2003

Primary Completion Date

January 3, 2003

Eligibility Criteria

        Inclusion Criteria:

          -  documentation of a diagnosis of active acromegaly based on either of the following
             definitions:

               1. the patient has never received somatostatin analog nor dopaminergic agonist or
                  had previously received this medication but had stopped more than 3 months before
                  visit 1 and had a mean growth hormone (GH)level >5ng/mL at visit 1; or

               2. the patient was receiving treatment with a somatostatin analog (other than
                  lanreotide autogel) or a dopaminergic agonist at visit 1, had a mean GH >3ng/mL
                  at visit 2 (or visit 2a) and had at least a 100% increase in mean GH levels
                  between visit 1 and visit 2 (or visit 2a)

        Exclusion Criteria:

          -  receipt of radiotherapy for acromegaly within 3 years

          -  pituitary surgery within 3 months prior to visit 1

          -  prior receipt of lanreotide autogel or GH antagonist

          -  anticipated need for pituitary surgery (adenomectomy) or radiotherapy during the study
             period

          -  known hypersensitivity to any of the test materials or related compounds

          -  clinically significant renal or hepatic abnormalities

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ipsen Medical Director, ,

Location Countries

Czechia

Location Countries

Czechia

Administrative Informations

NCT ID

NCT00234572

Organization ID

E-28-52030-717

Responsible Party

Sponsor

Study Sponsor

Ipsen

Study Sponsor

Ipsen Medical Director, Study Director, Ipsen

Verification Date

August 2019