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Supersaturation and Precipitation of Diclofenac in the Stomach of Healthy Volunteers

NCT ID: NCT02007161

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-12-31

Brief Summary

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Investigate the supersaturation and precipitation behaviour of diclofenac in the stomach of healthy volunteers.

Detailed Description

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Conditions

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Supersaturation and Precipitation in the Stomach

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Nutritional State

Fed vs. Fasted State

Diclofenac potassium 50 mg

Group Type ACTIVE_COMPARATOR

Diclofenac potassium 50 mg

Intervention Type DRUG

Diclofenac potassium 50 mg

Use of a PPI

Nexiam (esomeprazole) 40 mg

Diclofenac potassium 50 mg

Group Type ACTIVE_COMPARATOR

Diclofenac potassium 50 mg

Intervention Type DRUG

Diclofenac potassium 50 mg

Interventions

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Diclofenac potassium 50 mg

Diclofenac potassium 50 mg

Intervention Type DRUG

Other Intervention Names

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Cataflam

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Jens Van Den Abeele

dhr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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EudraCT 2013-004636-29

Identifier Type: -

Identifier Source: org_study_id