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

This study has been withdrawn prior to enrollment.
(Administrative reasons)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00517491
First Posted: August 17, 2007
Last Update Posted: October 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ipsen
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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)

Resource links provided by NLM:


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 ]

Enrollment: 0
Study Start Date: May 2008
Estimated Study Completion Date: December 2008
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00517491     History of Changes
Other Study ID Numbers: A-38-52030-725
First Submitted: August 16, 2007
First Posted: August 17, 2007
Last Update Posted: October 1, 2015
Last Verified: June 2008

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Lanreotide
Angiopeptin
Somatostatin
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs