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
- Conditions
- AcromegalyGigantism10021112
- Registration Number
- NL-OMON38013
- Lead Sponsor
- Ipsen Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
1) The subject has given written informed consent prior to any study-related procedures.
2) The subject is male or female and is over 18 years of age.
3) The subject must have had documentation supporting the diagnosis of acromegaly.
4) The subject has been receiving octreotide 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.
5) If the subject is receiving dopamine agonist therapy, treatment should be stable for at least four months, and no change in their dopamine-agonist medication is expected during the entire study period.
1) The subject has received radiation therapy to the pituitary gland before study entry.
2) The subject has a history of hypersensitivity to lanreotide or drugs with a similar chemical structure.
3) The subject has received a GH receptor antagonist (pegvisomant) therapy within three months before study entry.
4) 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 120 mg, during the course of the study.
5) The subject has received any unlicensed drug within the 30 days prior to the baseline visit or is scheduled to receive an unlicensed drug during the course of the study.
6) The subject is anticipated to require pituitary surgery or to receive radiotherapy during the study.
7) The subject is likely to require treatment during the study with drugs that are not permitted by the study protocol (i.e., cyclosporine).
8) The subject is pregnant or lactating.
9) The subject is female and at risk of pregnancy during the study and is not using an acceptable contraceptive method. Females of childbearing potential must provide a negative pregnancy test at start of 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.
10) The subject has a history of, or known current, problems with alcohol or drug abuse.
11) The subject has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an unco-operative attitude.
12) The subject has abnormal baseline findings: any medical condition(s) and/or known laboratory findings that, in the opinion of the investigator, might jeopardise the subject*s safety or decrease the chance of obtaining satisfactory data to achieve the objective(s) of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Efficacy Endpoint(s) and Evaluation(s):<br /><br>The primary efficacy endpoint will be the percentage of subjects having<br /><br>maintained their injection interval schedule of six weeks or increased their<br /><br>injection interval to eight weeks whilst keeping their normalised IGF 1 levels<br /><br>(age and sex adjusted) at study end at Week 48. </p><br>
- Secondary Outcome Measures
Name Time Method