SWAN: Study on the Tolerance and Efficacy of a New Anti-r... | NCT02710955

Studies
SWAN: Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)

NCT02710955

Sponsor

United Pharmaceuticals

Status

Completed

Last Update Posted

Nov 14, 2017Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Gastroesophageal Reflux

Interventions

Thickened infant formula

Countries

Belgium

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

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2016

Primary Completion Date

Jan 21, 2017Actual

Completion Date

Apr 12, 2017Actual

First Submitted Date

Mar 8, 2016

First Submission Date that Met QC Criteria

Mar 11, 2016

First Posted Date

Mar 17, 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

Nov 13, 2017

Last Update Posted Date

Nov 14, 2017Actual

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

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thickened infant formula	Experimental		Dietary Supplement: Thickened infant formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thickened infant formula	Dietary Supplement		Thickened infant formula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of episodes of regurgitation per day		14 days

Secondary Outcomes

Measure	Description	Time Frame
Regurgitation score assessed through Vandenplas score		14 and 90 days
Stools frequency over 72h		14 and 90 days
Stools consistency assessed through Bristol Stool form Scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infants :
- Aged ≤ 5 months old
- fully formula fed
- with at least 5 episodes of regurgitation per day, for at least a week

Exclusion Criteria:

Breast fed infants
Infants presenting symptoms of a complicated gastroesophageal reflux
Infants presenting intestinal disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Week

Maximum Age

5 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yvan Vandenplas, MD	Universitair Ziekenhuis Brussel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitair Ziekenhuis		Brussels			Belgium

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided