Effect of 120mg Somatuline Autogel at Different Dose Intervals (28, 42 or 56 Days) in Patients With Acromegaly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00444873
First received: March 7, 2007
Last updated: June 18, 2012
Last verified: June 2012

March 7, 2007
June 18, 2012
January 2005
January 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00444873 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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.
  • 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
  • Patient symptoms and quality of life on Lanreotide Autogel and comparison to previous Octreotide LAR treatment.
Not Provided
Not Provided
 
Effect of 120mg Somatuline Autogel at Different Dose Intervals (28, 42 or 56 Days) in Patients With Acromegaly
A Phase III, Multicentre, Open Label, Comparative, Dose-interval Titration Study Evaluating the Efficacy and Safety of Six Repeated Deep Subcutaneous Administrations of Lanreotide Autogel 120mg, in Acromegalic Patients Previously Treated With Octreotide LAR

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

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acromegaly
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.
  • Experimental: 28 day dose interval
    Intervention: Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval
  • Experimental: 42 day dose interval
    Intervention: Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval
  • Experimental: 56 day dose interval
    Intervention: Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval
Schopohl J, Strasburger CJ, Caird D, Badenhoop K, Beuschlein F, Droste M, Plöckinger U, Petersenn S; German Lanreotide Study Group. Efficacy and acceptability of lanreotide Autogel® 120 mg at different dose intervals in patients with acromegaly previously treated with octreotide LAR. Exp Clin Endocrinol Diabetes. 2011 Mar;119(3):156-62. doi: 10.1055/s-0030-1267244. Epub 2010 Nov 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00444873
A-94-52030-163
No
Ipsen
Ipsen
Not Provided
Study Director: David Caird, PhD Ipsen
Ipsen
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP