Supersaturation and Precipitation of Diclofenac in the Stomach of Healthy Volunteers (DDD13DICLO)

December 10, 2013 updated by: Jens Van Den Abeele, KU Leuven
Investigate the supersaturation and precipitation behaviour of diclofenac in the stomach of healthy volunteers.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers
  • Age 20 - 35 years

Exclusion Criteria:

  • Illness
  • Acute / Chronic gastric disorder
  • Use of medicine
  • (possible) pregnancy
  • Frequent exposure to X-rays during the past year
  • HIV / Hepatitis B Virus or Hepatitis C Virus infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nutritional State

Fed vs. Fasted State

Diclofenac potassium 50 mg
Drug: Diclofenac potassium 50 mg
Diclofenac potassium 50 mg
Other Names:
  • Cataflam
Active Comparator: Use of a PPI

Nexiam (esomeprazole) 40 mg

Diclofenac potassium 50 mg
Drug: Diclofenac potassium 50 mg
Diclofenac potassium 50 mg
Other Names:
  • Cataflam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the Concentration - Time Curve
Time Frame: Every 10 minutes for 2 h
Every 10 minutes for 2 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (Estimate)

December 10, 2013

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT 2013-004636-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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