DRUG
lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval
Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.
Status
Completed
Phase
Phase 3
Enrollment
38
Locations
1
Results
Not posted
Publications
1
Study 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.
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
Interventions
DRUG
Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.
Timeline
First posted
Mar 8, 2007
Study start
Jan 2005
Primary completion
Jan 2008
Study completion
Jan 2008
Results posted
Not reported
Registry updated
Nov 22, 2019
Outcomes
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.
Time frame · 1 dose interval after the last administration of Lanreotide Autogel 120mg
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.
Time frame · Last three injections of Lanreotiude Autogel 120mg
Dose interval, 28, 42 or 56 days for repeated injections of Lanreotide Autogel 120mg, which shows comparable efficacy to the previous treatment with Octreotide LAR 10, 20 or 30 mg in controlling IGF-1 and GH levels
Time frame · Interval between doses after titration in part 2 of treatment (injections 3-6)
Patient symptoms and quality of life on Lanreotide Autogel and comparison to previous Octreotide LAR treatment.
Time frame · 1 dose interval after the last administration of Lanreotide Autogel 120mg
Eligibility
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
Study locations
Germany. Showing up to 24 locations stored in the fast local snapshot.
Klinikum Innenstadt
Munich, Germany
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