Study to Evaluate Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG) - Full Text View

Purpose

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	Intervention	Phase
Acromegaly	Drug: lanreotide (Autogel formulation)	Phase II

ChemIDplus related topics:

Insulin-like growth factor I Mecasermin rinfabate Lanreotide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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)

Further study details as provided by Ipsen:

Primary Outcome Measures:

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. [ Time Frame: Weeks 16, 18 & 20 ]
Acromegaly symptoms. [ Time Frame: Weeks 16, 18 & 20 ]
Indices of insulin secretion & sensitivity [ Time Frame: Weeks 16, 18 & 20 ]
Adverse events [ Time Frame: Throughout study ]

Secondary Outcome Measures:

Number of patients with GH levels ≤ 2.5 ng/mL and the number of patients with IGF-1 level < upper limit of normal (ULN). [ Time Frame: Weeks 16, 18 & 20. ]
Serum lanreotide Autogel 120 mg concentrations. [ Time Frame: Weeks 16, 18 & 20. ]
ECG and gallbladder ultrasound [ Time Frame: Week 20 ]

Estimated Enrollment:	10
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
1: Experimental	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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517491

Locations


Mexico
	Centro Médico Nacional Siglo XXI, IMSS
	Mexico City, Mexico, 06720

Sponsors and Collaborators

Ipsen

Investigators


Study Director:	Marcus V. Chio Ming Coelho de Sa, MD	Ipsen

Principal Investigator:	Moises Mercado Atri, MD	Ipsen

More Information

Study ID Numbers:	A-38-52030-725
First Received:	August 16, 2007
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00517491
Health Authority:	Mexico: Federal Commission for Protection Against Health Risks

Study placed in the following topic categories:

Bone Diseases, Endocrine

Hypothalamic Diseases

Lanreotide

Pituitary Diseases

Musculoskeletal Diseases

Angiopeptin

Endocrine System Diseases

Central Nervous System Diseases

Endocrinopathy

Brain Diseases

Bone Diseases

Acromegaly

Additional relevant MeSH terms:

Hyperpituitarism

Antineoplastic Agents

Therapeutic Uses

Nervous System Diseases

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00517491