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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00517491
Other study ID # A-38-52030-725
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date May 2008
Est. completion date December 2008

Study information

Verified date August 2019
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Mexico Centro Médico Nacional Siglo XXI, IMSS Mexico City

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Acromegaly symptoms. Weeks 16, 18 & 20
Primary Indices of insulin secretion & sensitivity Weeks 16, 18 & 20
Primary Adverse events Throughout study
Secondary 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.
Secondary Serum lanreotide Autogel 120 mg concentrations. Weeks 16, 18 & 20.
Secondary ECG and gallbladder ultrasound Week 20
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