Acceptability Study on Oral Nutrition Supplement (ONS)
Acceptability Study on Nutricomp Drink Plus in Adult Patients
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedOctober 13, 2016
October 1, 2016
3 months
June 24, 2015
October 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (3)
Occurrence of further adverse effects
7 days
Evaluation of palatability by questionnaire
1 day
Evaluation of compliance.
7 days
Study Arms (1)
1 Nutricomp Drink Plus
EXPERIMENTALNutricomp Drink Plus
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheffield Teaching Hospitals NHS Foundation Trust, The Royal Hallamshire Hospital, Regional Gastrointestinal and Liver Unit
Sheffield, S10 2JF, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
David Sanders, Prof.
The Royal Hallamshire Hospital,Regional Gastrointestinal and Liver Unit, Sheffield, UK
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2015
First Posted
September 2, 2015
Study Start
July 1, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
October 13, 2016
Record last verified: 2016-10