Study in Polish Acromegalic Patients Treated With Somatuline Autogel
This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
First received: April 8, 2011
Last updated: April 29, 2014
Last verified: April 2014
The purpose of this study is to evaluate over the 24 month prospective follow up - in everyday clinical practice - resource utilization and effectiveness of the treatment of acromegalic patients in Poland with Somatuline Autogel 120 mg including extended injection intervals.
||A Non-Interventional Retrospective (12 Months) and Prospective (at Least 24 Months) Resource Utilization Study, in the Population of Polish Acromegalic Patients Treated With Somatuline Autogel at Normal (4 Weeks) or Extended (6 or 8 Weeks) Dosing Interval
Primary Outcome Measures:
- Percentage variation of Insulin-like growth factor-1 (IGF-1) levels [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean growth hormone (GH) levels [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Proportion of patients with GH levels below 1.0 microgram/liter [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Observation of 150 patients out of 500 routinely treated with somatostatin analogues in Poland
- Adult patients with acromegaly treated for at least three injections with Somatuline Autogel 120 mg
- Subjects must be treated for acromegaly for at least 1 year, with medical treatment prior to inclusion. One year historical data must be available
- Active participation in any interventional or any other non-interventional acromegaly clinical study. Previous participation in observational / post-marketing study of other somatostatin analogue should not be an exclusion criteria
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01333384
|Ipsen Central Contact
|Warsaw, Poland |
||Andrzej Suwala, M.D. PhD.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 8, 2011
||April 29, 2014
||Poland: Not required
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Bone Diseases, Endocrine
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases