Effect of 120mg Somatuline Autogel at Different Dose Intervals (28, 42 or 56 Days) in Patients With Acromegaly

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Acromegaly
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Brief Title

Effect of 120mg Somatuline Autogel at Different Dose Intervals (28, 42 or 56 Days) in Patients With Acromegaly

Official Title

A Phase III, Multicentre, Open Label, Comparative, Dose-interval Titration Study Evaluating the Efficacy and Safety of Six Repeated Deep Subcutaneous Administrations of Lanreotide Autogel 120mg, in Acromegalic Patients Previously Treated With Octreotide LAR

Brief Summary

      A multicentre, prospective, open label study of acromegalic patients evaluating the efficacy
      and safety of different dose-intervals of Lanreotide Autogel 120mg according to international
      standards and compared to previous treatment with Octreotide LAR 10, 20 or 30 mg.

Detailed Description

      Six repeated applications of Lanreotide Autogel 120mg administered every 28, 42 or 56 days.
      For the first three injections, the interval depends on the Octreotide LAR dosage
      administered previously. The dose interval is titrated after injection 3 depending on the
      efficacy of the therapy with Lanreotide Autogel

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Mean Insulin like Growth Factor 1 (IGF-1) and Growth Hormone (GH) levels at the beginning and end of the study and as proportion of patients conforming to internationally accepted levels.

Secondary Outcome

 Dose interval, 28, 42 or 56 days for repeated injections of Lanreotide Autogel 120mg which are effective in reducing IGF-1 and GH levels to internationally accepted levels.

Condition

Acromegaly

Intervention

lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval

Study Arms / Comparison Groups

 28 day dose interval
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

38

Start Date

January 2005

Completion Date

January 2008

Primary Completion Date

January 2008

Eligibility Criteria

        Inclusion Criteria:

          -  The patient must give written (personally signed and dated) informed consent before
             completing any study-related procedure.

          -  The patient must have a documented diagnosis of active acromegaly and be adequately
             treated with a stable dose (10, 20 or 30 mg) of Octreotide LAR for at least 6 months
             immediately prior to study entry. A documented diagnosis of active acromegaly is
             defined as IGF-1 more than 30% higher than two Standard Deviations ( +2 SD) above the
             normal age and sex adjusted value (see Appendix 6) or GH level after OGTT (Oral
             Glucose Tolerance Test) > 2ng/mL while not under drug treatment for acromegaly. For
             patients having undergone surgery or radiotherapy, this diagnosis must have been
             performed after the most recent surgical or radiation treatment

        Exclusion Criteria:

          -  The patient has had pituitary surgery (adenomectomy) within 6 months prior to study
             entry

          -  The patient has received stereotactic (LINAC, Gamma Knife) radiotherapy for acromegaly
             within three years or conventional radiotherapy for acromegaly within five years prior
             to study entry

Gender

All

Ages

25 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ipsen Medical Director, ,

Location Countries

Germany

Location Countries

Germany

Administrative Informations

NCT ID

NCT00444873

Organization ID

A-94-52030-163

Secondary IDs

2004-001435-33

Responsible Party

Sponsor

Study Sponsor

Ipsen

Study Sponsor

Ipsen Medical Director, Study Director, Ipsen

Verification Date

November 2019