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
  Purpose

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.


Condition Intervention Phase
Acromegaly
Drug: lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 38
Study Start Date: January 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 28 day dose interval 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: 42 day dose interval 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: 56 day dose interval 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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444873

Locations
Germany
Klinikum Innenstadt
Munich, Germany, 80336
Sponsors and Collaborators
Ipsen
Investigators
Study Director: David Caird, PhD Ipsen
  More Information

Publications:
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00444873     History of Changes
Other Study ID Numbers: A-94-52030-163
Study First Received: March 7, 2007
Last Updated: June 18, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ipsen:
Inappropriate Growth Hormone Secretion Syndrome (Acromegaly)

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Lanreotide
Angiopeptin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 16, 2014