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

Primary Purpose

Acromegaly

Status

Withdrawn

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

lanreotide (Autogel formulation)

About this trial

This is an interventional treatment trial for Acromegaly

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Centro Médico Nacional Siglo XXI, IMSS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

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.

Acromegaly symptoms.

Indices of insulin secretion & sensitivity

Adverse events

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).

Serum lanreotide Autogel 120 mg concentrations.

ECG and gallbladder ultrasound

Full Information

NCT ID

NCT00517491

First Posted

August 16, 2007

Last Updated

August 1, 2019

Sponsor

Ipsen

1. Study Identification

Unique Protocol Identification Number

NCT00517491

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Administrative reasons

Study Start Date

May 2008 (undefined)

Primary Completion Date

December 2008 (Anticipated)

Study Completion Date

December 2008 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ipsen

4. Oversight

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acromegaly

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

lanreotide (Autogel formulation)

Intervention Description

120 mg administered every 28 days via deep subcutaneous injection. A total of 4 injections will be administered during the study.

Primary Outcome Measure Information:

Title

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

Title

Acromegaly symptoms.

Time Frame

Weeks 16, 18 & 20

Title

Indices of insulin secretion & sensitivity

Time Frame

Weeks 16, 18 & 20

Title

Adverse events

Time Frame

Throughout study

Secondary Outcome Measure Information:

Title

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.

Title

Serum lanreotide Autogel 120 mg concentrations.

Time Frame

Weeks 16, 18 & 20.

Title

ECG and gallbladder ultrasound

Time Frame

Week 20

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ipsen Medical Director

Organizational Affiliation

Ipsen

Official's Role

Study Director

Facility Information:

Facility Name

Centro Médico Nacional Siglo XXI, IMSS

City

Mexico City

ZIP/Postal Code

06720

Country

Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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