Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00600678
Other study ID # N-PRX-02-DE
Secondary ID
Status Completed
Phase N/A
First received January 7, 2008
Last updated May 14, 2008
Start date November 2007
Est. completion date January 2008

Study information

Verified date May 2008
Source Fresenius Kabi
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

Measurement of gastric emptying time of an oral nutritional supplement (ProvideXtra DRINK) by using the paracetamol absorption method in healthy volunteers.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date January 2008
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- caucasian origin

- BMI: 22kg/m2 - 27kg/m2;

Exclusion Criteria:

- 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;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
ProvideXtra DRINK (oral nutritional supplement, food for special medical purposes)
Single, oral administration of nutritional supplement under fasting condition within 2 minutes.

Locations

Country Name City State
Germany SocraTec R&D GmbH, Clinical Pharmacology Unit Erfurt Thueringen

Sponsors (1)

Lead Sponsor Collaborator
Fresenius Kabi

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary - Gastric emptying after a single oral administration of a nutritional supplement Time frame gastric emptying: blood samples will be taken at predefined time points, up to 12h after application of test product. No
Secondary safety and tolerability entire study No
See also
  Status Clinical Trial Phase
Completed NCT02913677 - Prolonged Minimal Enteral Nutrition Versus Slowly Advancing Enteral Nutrition in Very Low Birth Weight Infants: N/A
Not yet recruiting NCT00916591 - Prokinetic Drugs and Enteral Nutrition N/A
Completed NCT01025167 - The Effect of a New Specific Enteral Formula Compared to a Standard Formula on the Tolerability of a Combined Radio- and Chemotherapy in Cancer Patients N/A
Not yet recruiting NCT05900323 - Enteral Nutrition Guidelines and Patients' Outcomes N/A
Completed NCT03153397 - Effect of Prebiotic Fiber- Enriched (scFOS) Enteral Feeding on the Microbiome in Neurological Injury Trauma Patients (PreFEED Microbiome Trial) N/A
Completed NCT02353689 - The Effect of FODMAP Content in Tube Feeding Formula on Feeding Intolerance and Nutritional Status Improvement Phase 2/Phase 3
Terminated NCT00564655 - Regional Anesthesia Block of the Transversus Abdominis Plane in Children Undergoing Gastric Tube Insertion Phase 3
Completed NCT06134674 - Early Versus Delayed Enteral Nutrition in Critically Ill Adults With COVID-19
Recruiting NCT03791866 - The Th9/IL-9 and Early Enteral Nutrition in Sepsis N/A
Enrolling by invitation NCT06161350 - The Multi-disciplinary Approach of Children With Feeding Difficulties and Tube Feeding in UZB Between 2000 and 2021
Active, not recruiting NCT02724631 - TubeClear® Evaluation in Pediatric Patients (Phase I) N/A
Completed NCT01988792 - Human Milk Fortification in Very Low Birth Neonates N/A
Completed NCT02998931 - Trial of Enteral Glutamine on Clinical Outcomes in Critically Ill Patients Phase 3
Not yet recruiting NCT06411873 - The Effect of High Protein Enteral Nutrition on Critically Ill Postoperative Children N/A
Recruiting NCT03176875 - Comparison of Partial and Exclusive Enteral Nutrition in the Treatment of Active Childhood-onset Crohn's Disease N/A
Completed NCT02779335 - Enteral Formula Tolerance in Pediatric Patients N/A
Completed NCT05411848 - 2kcal Tube Feed Study N/A
Completed NCT04868318 - The Impact of Intervention With High-protein Enteral Formula in SICU. N/A
Withdrawn NCT04601571 - Confirming Feeding Tube Position Using CORTRAK N/A
Not yet recruiting NCT06239610 - DrIFT 2 Study: Displacement in Feeding Tubes N/A