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