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.
Study to Evaluate Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG)
Status
Withdrawn
Phase
Phase 2
Enrollment
0
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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)
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Aug 17, 2007
Study start
May 2008
Primary completion
Dec 2008
Study completion
Dec 2008
Results posted
Not reported
Registry updated
Aug 5, 2019
Outcomes
What the study measures.
Primary outcomes
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 outcomes
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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Sex
- ALL
- 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.
Study locations
1 registered sites.
Mexico. Showing up to 24 locations stored in the fast local snapshot.
Centro Médico Nacional Siglo XXI, IMSS
Mexico City, Mexico
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.