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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This study has been withdrawn prior to enrollment.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:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00517491
First received: August 16, 2007
Last updated: June 18, 2008
Last verified: June 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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
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

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

No publications provided

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

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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013