Therapeutic Strategies in Acromegalic Subjects Treated Wi... | NCT02698384

Studies
Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg

NCT02698384

Sponsor

Ipsen

Status

Terminated

Last Update Posted

Dec 21, 2018Actual

Enrollment

4Actual

Phase

Not provided

Conditions

Acromegaly

Interventions

Not provided

Countries

France

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

Dec 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was terminated early due to insufficient potential for recruitment.

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Jan 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Feb 26, 2016

First Submission Date that Met QC Criteria

Feb 26, 2016

First Posted Date

Mar 3, 2016Estimated

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

Dec 20, 2018

Last Update Posted Date

Dec 21, 2018Actual

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

Description Module

Brief Summary

The study aims to evaluate the biochemical and clinical effectiveness on symptoms and tumor size of a monotherapy with Lanreotide 120mg in acromegalic subjects, to describe criteria for starting alternative strategies, and to describe the modalities and the global effectiveness of alternative strategies.

Detailed Description

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

4Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of subjects who achieve a safe concentration of random Growth Hormone (GH) (≤2.5 ng/mL) and normal age and sex-matched Insulin-like Growth Factor-1 (IGF-1) concentration of the monotherapy phase.		Month 5

Secondary Outcomes

Measure	Description	Time Frame
Profile of subjects	Description of demographics, Patient-Assessed Acromegaly Symptom Questionnaire (PASQ) clinical score, PASQ overall health status, tumor volume, comorbidities, GH and IGF-1 levels	Baseline
History of acromegaly

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female aged 18 years or more, suffering from acromegaly
Treatment naïve or treated subject (whatever the previous treatments except Lanreotide 120mg and radiotherapy) who does not achieve biochemical control in the physician's opinion. Requiring a treatment with Somatostatin analog (SSA)
Having performed a Magnetic Resonance Imaging (MRI) to evaluate the tumor size within the previous 12 weeks (post-surgery MRI for operated subjects)
In whom the physician has already decided to initiate a treatment with Lanreotide 120mg as a monotherapy

Exclusion Criteria:

Subject previously/currently treated with Lanreotide 120mg
History of radiotherapy for acromegaly
Subject who requires a surgical intervention for relief of any sign or symptom associated with tumor compression
Concomitant prolactin hypersecretion requiring a treatment with dopaminergic agonists
Active neoplastic disease

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

Acromegalic subjects

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Ipsen Medical Director	Ipsen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Hoptial Nord		Amiens		80054	France
Hopital jean Minjoz

Condition Browse Module

MeSH Terms

ID	Term
D000172	Acromegaly

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided