Enteral NutritionNCT00600678
Gastric Emptying Study After Administration of a High Caloric Sip Feed
A study testing ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes) in people with Enteral Nutrition, run by Fresenius Kabi at 1 site in Germany.
Trial summary
Measurement of gastric emptying time of an oral nutritional supplement (ProvideXtra DRINK) by using the paracetamol absorption method in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Enteral Nutrition
- What is being tested?
- ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2007to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- caucasian origin
- BMI: 22kg/m2 - 27kg/m2;
Who cannot join
- existing diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of paracetamol (e.g. gastrointestinal or liver disease),
- known allergic reactions to investigational products,
- diseases and/or pathological findings, which could affect absorption, metabolism and/or gastric emptying (e.g. dyspepsia and gastroesophageal reflux),
- regular medication which can influence hepatic biotransformation and/or absorption,
- alcohol dependence, blood donation;
Trial locations and contacts
1 site in 1 country.
Germany1 site
SocraTec R&D GmbH, Clinical Pharmacology Unit
Erfurt, Thuringia, 99084
About this study
Official title: Characterisation of Gastric Emptying of a High Caloric Sip Feed Using the Paracetamol Absorption Method: Intraindividual Comparison of Paracetamol Pharmacokinetics After Oral co-Administration With Sip-Feed and After Intravenous Administration in Healthy Volunteers of Both Genders in an Open, Single Centre Study
Measurement of gastric emptying time of an oral nutritional supplement (ProvideXtra DRINK) by using the paracetamol absorption method in healthy volunteers.
- Conditions
- Enteral Nutrition
- Being tested
- ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes)
- Keywords
- food for special medical purposes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes)Dietary supplement
Single, oral administration of nutritional supplement under fasting condition within 2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Gastric emptying after a single oral administration of a nutritional supplement
Measured: Time frame gastric emptying: blood samples will be taken at predefined time points, up to 12h after application of test product.
Secondary outcomes (1)
safety and tolerability
Measured: entire study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frank Donath, MD, Principal investigator, SocraTec R&D GmbH, Clinical Pharmacology Unit, Erfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600678
- Sponsor's protocol ID
- N-PRX-02-DE
- Status last verified
- May 2008
- First submitted
- 7 Jan 2008
- Last updated
- 15 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Gastric Emptying of a High Caloric Sip Feed Using the Paracetamol Absorption Method: Intraindividual Comparison of Paracetamol Pharmacokinetics After Oral co-Administration With Sip-Feed and After Intravenous Administration in Healthy Volunteers of Both Genders in an Open, Single Centre Study
- ClinicalTrials.gov ID
- NCT00600678
- Acronym / sponsor ID
- N-PRX-02-DE
- Conditions
- Enteral Nutrition
- Keywords
- food for special medical purposes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 25 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Measurement of gastric emptying time of an oral nutritional supplement (ProvideXtra DRINK) by using the paracetamol absorption method in healthy volunteers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- caucasian origin
- BMI: 22kg/m2 - 27kg/m2;
Key exclusion criteria (5 listed)
- existing diseases and/or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of paracetamol (e.g. gastrointestinal or liver disease),
- known allergic reactions to investigational products,
- diseases and/or pathological findings, which could affect absorption, metabolism and/or gastric emptying (e.g. dyspepsia and gastroesophageal reflux),
- regular medication which can influence hepatic biotransformation and/or absorption,
- alcohol dependence, blood donation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes)Single, oral administration of nutritional supplement under fasting condition within 2 minutes. | Dietary supplement | 1 |
Primary outcome
- Gastric emptying after a single oral administration of a nutritional supplement
Time frame: Time frame gastric emptying: blood samples will be taken at predefined time points, up to 12h after application of test product.
1 secondary outcome
safety and tolerability
Time frame: entire study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Donath, MD principal investigator
SocraTec R&D GmbH, Clinical Pharmacology Unit, Erfurt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes) in people with Enteral Nutrition, run by Fresenius Kabi at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Gastric emptying after a single oral administration of a nutritional supplement (time frame: Time frame gastric emptying: blood samples will be taken at predefined time points, up to 12h after application of test product.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2008.