Acceptability Study on Oral Nutrition Supplement (ONS) | NCT02538250

Studies
Acceptability Study on Oral Nutrition Supplement (ONS)

NCT02538250

Sponsor

B. Braun Medical UK Ltd.

Status

Completed

Last Update Posted

Oct 13, 2016Estimated

Enrollment

23Actual

Phase

Phase 4

Conditions

Oral Nutritional Supplementation

Interventions

Nutricomp Drink Plus

Countries

United Kingdom

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

Oct 2016

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

Jul 2015

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Jun 24, 2015

First Submission Date that Met QC Criteria

Sep 1, 2015

First Posted Date

Sep 2, 2015Estimated

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

Oct 12, 2016

Last Update Posted Date

Oct 13, 2016Estimated

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

Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus to show that it is acceptable for patients in the United Kingdom.

Detailed Description

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 Nutricomp Drink Plus	Experimental	Nutricomp Drink Plus	Dietary Supplement: Nutricomp Drink Plus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nutricomp Drink Plus	Dietary Supplement	Oral nutritional supplementation	1 Nutricomp Drink Plus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of gastrointestinal tolerance parameters (Diarrhoea, Constipation, Bloating, Distension, Nausea, Vomiting, Burping, Regurgitation, Flatulence, Abdominal discomfort, Abdominal pain, Other (further gastrointestinal adverse events)	Parameters asked as required for acceptability studies by Advisory Committee for Borderline Substances- documented in a patient diary	7 days

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of further adverse effects		7 days
Evaluation of palatability by questionnaire	Five point hedonic scale	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion:

Male and female patients
≥ 18 years of age
Patients of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 7 days
Patient is able and willing to provide written informed consent

Exclusion:

Hypersensitivity to milk, whey, soy, fish or any of the active substances or excipients
Patients with available or potential impairment of sense of taste or smell due to disease (e.g. patients with cold, cancer patients) or medication (e.g. D-Penicillamine)
Patients who express general dislike to two or more of the four flavours
Severely impaired gastrointestinal function or complete failure
Severe metabolic or circulatory disorders
Acute disease
Unstable vital functions
Necessity of total parenteral nutrition or more than 50% Parenteral Nutrition in combined therapy
Simultaneous participation in another interventional study
Patients who are unwilling or mentally and/or physically unable to adhere to study procedures
Pregnancy
Emergencies

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Sanders, Prof.	The Royal Hallamshire Hospital,Regional Gastrointestinal and Liver Unit, Sheffield, UK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheffield Teaching Hospitals NHS Foundation Trust, The Royal Hallamshire Hospital, Regional Gastrointestinal and Liver Unit		Sheffield		S10 2JF	United Kingdom