Predictive Factors Study

NCT02020499 | Terminated

• 1 other identifier: A-9B-52030-265
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 6

Brief Summary

This is a long term study to evaluate common therapeutic algorithms and possible predictive parameters for Somatuline Autogel treatment in patients with Acromegaly.

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

• Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline

  Baseline and 4 weeks

Secondary Outcomes (1)

• Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline

  Baseline, 1 year and 3 years

Study Arms (1)

Acromegalic patients

Acromegalic subjects treated with Somatuline Autogel® (Lanreotide)

Drug: Somatuline Autogel® (lanreotide) 60, 90, 120 mg.

Interventions

Somatuline Autogel® (lanreotide) 60, 90, 120 mg. DRUG

Patients receiving treatment as prescribed by the investigator and according to current treatment recommendations and routine clinical practice, and in line with local regulations.

Acromegalic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects in hospitals and private practices, suffering from acromegaly who are scheduled to receive ATG or already on treatment with ATG for a maximum of 3 months.

You may qualify if:

• Diagnosis of Acromegaly.
• Males and females aged 18 years and older.
• Signed informed consent (patient must give consent to the collection of retrospective data).
• Patients who have had surgery may enter the study 3 months post-surgery and evaluated for the duration of the study.
• If already being treated with ATG:
• Previous ATG treatment maximum of 3 months. AND Minimum data available (demographic data, disease history including previous treatments, GH, IGF-1 levels at baseline and under treatment as applicable).
• Not receiving Dopamine Agonists or other medical therapy (Pegvisomant, or other somatostatin analogues) for the treatment or symptom control of acromegaly.

You may not qualify if:

• The subject has had radiotherapy in the last 5 years.
• The subject has had surgery in the last 3 months.
• The subject has already been included in this study.
• Participation in an interventional trial, or receiving experimental drug.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (6)

St Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Royal Brisbane & Women's Hospital

Herston, Queensland, 4006, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

St Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

The Austin Hospital

Heidelberg, Victoria, 3084, Australia

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: December 25, 2013
• Study Start: August 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 14, 2019

Record last verified: 2019-01

Locations

AU (6)