Brief Title
Study to Assess the Efficacy of an Extended Injection Interval Schedule of Lanreotide Autogel in Acromegalic Subjects
Official 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
Brief Summary
The purpose of the study is to assess the efficacy of an extended injection interval schedule
of lanreotide Autogel 120 mg in acromegalic subjects who are biochemically controlled on long
term treatment with octreotide LAR 10 or 20 mg
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Percentage of Subjects Having Maintained Their Injection Interval Schedule of Six Weeks or Increased Their Injection Interval to Eight Weeks Whilst Keeping Their Normalised Insulin Growth Factor (IGF-1) Levels (Age and Sex Adjusted)
Secondary Outcome
Percentage of Subjects With Normalised IGF-1 Levels (Age and Sex Adjusted)
Condition
Acromegaly
Intervention
Lanreotide Autogel 120 mg
Study Arms / Comparison Groups
Lanreotide Autogel 120 mg
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
124
Start Date
October 2008
Completion Date
May 2013
Primary Completion Date
March 2013
Eligibility Criteria
Inclusion Criteria:
- 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 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
- 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
Exclusion Criteria:
- 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 growth hormone 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 120 mg, during the course of the study
- 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ipsen Medical Director, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT00701363
Organization ID
A-38-52030-214
Secondary IDs
2007-005838-37
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical Director, Study Director, Ipsen
Verification Date
January 2019