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

NCT00517491 | Withdrawn Phase 2

• 1 other identifier: A-38-52030-725
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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)

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (4)

• 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

• Acromegaly symptoms.

  Weeks 16, 18 & 20

• Indices of insulin secretion & sensitivity

  Weeks 16, 18 & 20

• Adverse events

  Throughout study

Secondary Outcomes (3)

• 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.

• Serum lanreotide Autogel 120 mg concentrations.

  Weeks 16, 18 & 20.

• ECG and gallbladder ultrasound

  Week 20

Study Arms (1)

1

EXPERIMENTAL

Drug: lanreotide (Autogel formulation)

Interventions

lanreotide (Autogel formulation) DRUG

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

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

Centro Médico Nacional Siglo XXI, IMSS

Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

Acromegaly

Interventions

lanreotide

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2007
• First Posted: August 17, 2007
• Study Start: May 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 5, 2019

Record last verified: 2019-08

Locations

ME (1)