NCT01333384

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

January 7, 2019

Status Verified

January 1, 2019

Enrollment Period

3.7 years

First QC Date

April 8, 2011

Last Update Submit

January 4, 2019

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (1)

  • Percentage variation of Insulin-like growth factor-1 (IGF-1) levels

    24 months

Secondary Outcomes (2)

  • Mean growth hormone (GH) levels

    24 months

  • Proportion of patients with GH levels below 1.0 microgram/liter

    24 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Observation of 150 patients out of 500 routinely treated with somatostatin analogues in Poland

You may qualify if:

  • Adult patients with acromegaly treated for at least three injections with Somatuline Autogel 120 mg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ipsen Central Contact

Warsaw, Poland

Location

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2011

First Posted

April 12, 2011

Study Start

October 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

January 7, 2019

Record last verified: 2019-01

Locations

PL(1)