Study to Evaluate Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG)

• Sponsor: Ipsen (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT00517491
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Duration (Months): 7
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of the protocol is to evaluate the correlation between plasma lanreotide levels and Growth Hormone (GH)/Insulin Like Growth Factor 1 (IGF-1) dynamics and clinical improvement in patients with acromegaly treated with lanreotide Autogel (Somatuline ATG)

Condition or Disease	Intervention/Treatment	Phase
Acromegaly	Drug: lanreotide (Autogel formulation)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study to Evaluate the Correlation Between Plasma Lanreotide Levels and GH/IGF-1 Dynamics and Clinical Improvement in Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG)
• Study Start Date: May 1, 2008
• Anticipated Primary Completion Date: Dec 1, 2008
• Anticipated Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: lanreotide (Autogel formulation); 120 mg administered every 28 days via deep subcutaneous injection. A total of 4 injections will be administered during the study.

Outcome Measures

Primary Outcome Measures

1. GH (basal and during Oral Glucose Tolerance Test (OGTT)) and IGF-1 levels, in acromegalic patients previously treated with octreotide long acting release (LAR) 20 mg. [Weeks 16, 18 & 20]

2. Acromegaly symptoms. [Weeks 16, 18 & 20]

3. Indices of insulin secretion & sensitivity [Weeks 16, 18 & 20]

4. Adverse events [Throughout study]

Secondary Outcome Measures

1. Number of patients with GH levels ≤ 2.5 ng/mL and the number of patients with IGF-1 level < upper limit of normal (ULN). [Weeks 16, 18 & 20.]

2. Serum lanreotide Autogel 120 mg concentrations. [Weeks 16, 18 & 20.]

3. ECG and gallbladder ultrasound [Week 20]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient on treatment with octreotide LAR 20 mg administered every 28 days for at least 3 months prior to visit 1.

• Patient must have serum GH level ≤ 2.5 ng/mL and serum IGF-1 ≤ 1.3 ULN, 28 days after their last injection of octreotide LAR 20 mg at visit 1.

• Patients must have serum GH level > 2.5 ng/mL AND serum IGF-1 level > 1.3 ULN, 6 or 8 weeks after their last injection of octreotide LAR 20 mg.

Exclusion Criteria:

• The patient has received pituitary radiation therapy of any kind at any time prior to visit 1.

• The patient has received pituitary surgery within 3 months prior to visit 1.

• The patient's serum creatinine is higher than 150 µmol/l.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Médico Nacional Siglo XXI, IMSS	Mexico City		Mexico	06720

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: NCT00517491
• Other Study ID Numbers: A-38-52030-725
• First Posted: Aug 17, 2007
• Last Update Posted: Aug 5, 2019
• Last Verified: Aug 1, 2019

• Additional relevant MeSH terms: Acromegaly; Lanreotide

Study Results

No Results Posted as of Aug 5, 2019