Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

• Sponsor: Ipsen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00216398
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Duration (Months): 24.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.

Condition or Disease	Intervention/Treatment	Phase
Acromegaly	Drug: Lanreotide (Autogel formulation)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase IV, Open-label, Single Group Study to Evaluate the Dosing, Efficacy and Safety of Lanreotide Autogel® in Patients With Acromegaly Previously Treated With Octreotide LAR
• Study Start Date: Jun 1, 2004
• Actual Primary Completion Date: Jun 22, 2006
• Actual Study Completion Date: Jun 22, 2006

Outcome Measures

Primary Outcome Measures

1. The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit. []

Secondary Outcome Measures

1. The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit. []

2. The percentage of patients with normalised IGF-1 compared to the baseline visit. []

3. Change in the GH values compared to the baseline (Week 0) visit. []

4. Change in the IGF-1 values compared to the baseline (Week 0) visit. []

5. Change in serum lanreotide levels compared to the baseline (Week 0) visit. []

6. Change in the serum octreotide levels compared to the baseline visit. []

7. Patient evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment. []

8. Investigator evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinical diagnosis of acromegaly

• The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and shown to have a GH level <10 mU/L.

• The patient must have been treated with a stable dose of octreotide LAR for at least four months prior to study entry

• Life expectancy of at least 2 years

Exclusion Criteria:

• Adenectomy within past 6 months, or likely during study period

• Radiotherapy for acromegalic disease within 1 year, or likely during study period

• Unstable concomitant dopamine agonist therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Westmead Hospital	Westmead	New South Wales	Australia	2145

Sponsors and Collaborators

• Ipsen

Investigators

• Study Director: Ipsen Study Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ipsen
• ClinicalTrials.gov Identifier: NCT00216398
• Other Study ID Numbers: A-9B-52030-159
• First Posted: Sep 22, 2005
• Last Update Posted: Aug 16, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Ipsen: acromegaly; growth hormone
• Additional relevant MeSH terms: Acromegaly; Lanreotide

Study Results

No Results Posted as of Aug 16, 2019