NCT02020499
Terminated
Not Applicable
Non-interventional, Observational, Long Term Study to Evaluate Common Therapeutic Algorithms and Possible Predictive Parameters for Somatuline Autogel (ATG) Treatment in Patients With Acromegaly.
ConditionsAcromegaly
InterventionsSomatuline Autogel® (lanreotide) 60, 90, 120 mg.
Overview
- Phase
- Not Applicable
- Intervention
- Somatuline Autogel® (lanreotide) 60, 90, 120 mg.
- Conditions
- Acromegaly
- Sponsor
- Ipsen
- Enrollment
- 5
- Locations
- 5
- Primary Endpoint
- Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •With the intention to be treated with ATG (decision to prescribe ATG made prior to inclusion into the study) or already being treated with ATG.
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Acromegalic patients
Acromegalic subjects treated with Somatuline Autogel® (Lanreotide)
Intervention: Somatuline Autogel® (lanreotide) 60, 90, 120 mg.
Outcomes
Primary Outcomes
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline
Time Frame: Baseline and 4 weeks
Secondary Outcomes
- Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline(Baseline, 1 year and 3 years)
Study Sites (5)
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