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

• Register: EUCTR
• Last refreshed on: 7 October 2014
• Main ID: EUCTR2007-005838-37-SE
• Date of registration: 21/04/2008
• Prospective Registration: Yes
• Primary sponsor: Beaufour Ipsen Pharma
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 15/05/2008
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005838-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Denmark, Finland, France, Greece, Latvia, Netherlands, Sweden

Key inclusion & exclusion 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
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.
- The subject has a history of, or known current, problems with alcohol or drug abuse.
- 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 uncooperative attitude.
- 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.
Under no circumstances will a subject be enrolled more than once.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Acromegaly
MedDRA version: 9.1 Level: LLT Classification code 10000599 Term: Acromegaly

Intervention(s)

Trade Name: Somatuline Autogel
Product Name: lanreotide Autogel 120 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: lanreotide
CAS Number: 108736352
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-

Primary Outcome(s)

Main Objective: To evaluate the efficacy of extended injection intervals (every 6 or 8 weeks) of lanreotide Autogel 120 mg in the control of insulin-like growth factor-1 (IGF-1) levels in adult subjects with acromegaly who are biochemically controlled with octreotide LAR (10 or 20 mg).

Primary end point(s): Percentage of subjects having maintained their injection interval schedule of 6 or increased their injection interval to 8 weeks whilst keeping their normalised IGF-1 levels (age and sex adjusted) at the end of the study.

Secondary Objective: • To compare baseline and end of study IGF-1 levels, according to injection interval, during the Phase 2 treatment period.
• To assess the predicting factor of baseline IGF-1 for extending the injection interval.
• To assess acromegaly symptoms.
• To evaluate quality of life, as assessed by the Acromegaly Quality of Life Questionnaire (AcroQoL) and Short Form-36 (SF-36).
• To assess the effect of lanreotide Autogel 120 mg extended injection intervals (every 6 or 8 weeks) on GH levels.
• To assess the safety of lanreotide Autogel 120 mg based on adverse events (AEs), clinical examinations, vital signs, and standard haematology and biochemistry.
• To determine subject preference for treatment schedule.

Secondary ID(s)

A-38-52030-214