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

Primary Purpose

Acromegaly

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Inappropriate Growth Hormone Secretion Syndrome (Acromegaly)

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Klinikum Innenstadt

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

28 day dose interval

42 day dose interval

56 day dose interval

Arm Description

Outcomes

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.

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.

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.

Full Information

NCT ID

NCT00444873

First Posted

March 7, 2007

Last Updated

November 21, 2019

Sponsor

Ipsen

1. Study Identification

Unique Protocol Identification Number

NCT00444873

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ipsen

4. Oversight

Data Monitoring Committee

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acromegaly

Keywords

Inappropriate Growth Hormone Secretion Syndrome (Acromegaly)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

28 day dose interval

Arm Type

Experimental

Arm Title

42 day dose interval

Arm Type

Experimental

Arm Title

56 day dose interval

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval

Intervention Description

Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

Title

Time Frame

Interval between doses after titration in part 2 of treatment (injections 3-6)

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ipsen Medical Director

Organizational Affiliation

Ipsen

Official's Role

Study Director

Facility Information:

Facility Name

Klinikum Innenstadt

City

Munich

ZIP/Postal Code

80336

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

21086246

Citation

Schopohl J, Strasburger CJ, Caird D, Badenhoop K, Beuschlein F, Droste M, Plockinger U, Petersenn S; German Lanreotide Study Group. Efficacy and acceptability of lanreotide Autogel(R) 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.

Results Reference

result

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

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