Predictive Factors Study | NCT02020499

Studies
Predictive Factors Study

NCT02020499

Sponsor

Ipsen

Status

Terminated

Last Update Posted

Jan 14, 2019Actual

Enrollment

5Actual

Phase

Not provided

Conditions

Acromegaly

Interventions

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

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Poor enrolment

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Dec 19, 2013

First Submission Date that Met QC Criteria

Dec 19, 2013

First Posted Date

Dec 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2019

Last Update Posted Date

Jan 14, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acromegalic patients		Acromegalic subjects treated with Somatuline Autogel® (Lanreotide)	Drug: Somatuline Autogel® (lanreotide) 60, 90, 120 mg.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline		Baseline and 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels from baseline		Baseline, 1 year and 3 years

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
St Vincent's Hospital		Darlinghurst	New South Wales	2010	Australia
Royal North Shore Hospital

ID	Term
D001849	Bone Diseases, Endocrine
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006964	Hyperpituitarism