We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00444873
Recruitment Status : Completed
First Posted : March 8, 2007
Last Update Posted : June 19, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

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

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2005
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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) ]
  3. 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 Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012

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
Somatostatin
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs