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

Sponsor

Ipsen (Industry)

Overall Status

Completed

CT.gov ID

NCT00444873

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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

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 :

Jan 1, 2005

Actual Primary Completion Date :

Jan 1, 2008

Actual Study Completion Date :

Jan 1, 2008

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.

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

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. [1 dose interval after the last administration of Lanreotide Autogel 120mg]

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. [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 [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. [1 dose interval after the last administration of Lanreotide Autogel 120mg]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinikum Innenstadt	Munich		Germany	80336

Sponsors and Collaborators

Ipsen

Investigators

Study Director: Ipsen Medical Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ipsen

ClinicalTrials.gov Identifier:

NCT00444873

Other Study ID Numbers:

A-94-52030-163
2004-001435-33

First Posted:

Mar 8, 2007

Last Update Posted:

Nov 22, 2019

Last Verified:

Nov 1, 2019

Keywords provided by Ipsen

Inappropriate Growth Hormone Secretion Syndrome (Acromegaly)

Additional relevant MeSH terms:

Acromegaly

Lanreotide

Study Results

No Results Posted as of Nov 22, 2019