A PROSPECTIVE, INTERNATIONAL, MULTI-CENTRIC, OPEN-LABEL STUDY TO ASSESS THE EFFICACY OF AN EXTENDED INJECTION INTERVAL SCHEDULE OF LANREOTIDE AUTOGEL 120 MG IN ACROMEGALIC SUBJECTS WHO ARE BIOCHEMICALLY CONTROLLED ON THE LONG TERM TREATMENT WITH OCTREOTIDE LAR 10 OR 20 MG

Beaufour Ipsen Pharma0 sites150 target enrollmentMay 29, 2008

DrugsLanreotide Autogel 120mg

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Beaufour Ipsen Pharma
Enrollment: 150
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 29, 2008

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Beaufour Ipsen Pharma

Eligibility Criteria

Inclusion Criteria

•All subjects must fulfil the following:
•\- The subject has given written informed consent prior to any study\-related procedures.
•\- The subject is male or female and is over 18 years of age.
•\- The subject must have had documentation supporting the diagnosis of acromegaly, based on elevated IGF\-1 and/or GH levels.
•\- The subject has been receiving Oct\-LAR (10 or 20 mg) treatment for at least six months and is biochemically controlled. Control is defined as normal (age and sex adjusted) IGF\-1 levels for two consecutive measurements (at least two months apart) preceding study entry.
•\- If the subject is receiving dopamine agonist therapy, treatment should be stable for at least four months, and no change in dopamine\-agonist medication is expected during the entire study period.
•Provision of written informed consent will be prior to any study related procedures.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

•Subjects will not be included in the study if:
•\- The subject has received radiation therapy to the pituitary gland before study entry.
•\- The subject has a history of hypersensitivity to lanreotide or drugs with a similar chemical structure
•\- The subject has received a GH receptor antagonist (pegvisomant) therapy within three months before study entry.
•\- The subject has undergone treatment with any other investigational drug in the 30 days before study entry or is scheduled to receive an investigational drug, other than Lanreotide, during the course of the study.
•\- The subject has received any unlicensed drug within the 30 days prior to the screening visit or is scheduled to receive an unlicensed drug during the course of the study.
•\- The subject is anticipated to require pituitary surgery or to receive radiation therapy during the study.
•\- The subject is likely to require treatment during the study with drugs that are not permitted by the study protocol (e.g., cyclosporine).
•\- The subject is pregnant or lactating.
•\- The subject is female and at risk of pregnancy during the study and is not using an acceptable method of contraception. Females of childbearing potential must provide a negative pregnancy test at the start of the study and must be using oral, double barrier (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide), injectable contraception or an intra\-uterine device. Non childbearing potential is defined as post\-menopause for at least one year, surgical sterilisation or hysterectomy at least three months before the start of the study.