NCT00190255

Brief Summary

Gastrointestinal bleeding is a severe adverse effect occurring in subjects secondary to the use of nonsteroidal anti-inflammatory drugs (NSAIDs). The enzyme CYP2C9 is responsible for the elimination of several NSAIDs. This protein is inactive in 12% of the subjects because of genetic mutations. We hypothesized that individuals carrying such mutations should be at higher risk of gastrointestinal bleeding since they display decreased NSAIDs elimination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2004

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

May 10, 2011

Status Verified

March 1, 2007

Enrollment Period

3.2 years

First QC Date

September 13, 2005

Last Update Submit

May 9, 2011

Conditions

Gastrointestinal HemorrhageStomach UlcerNon-steroidal Anti-inflammatory Drug Sensitivity

Keywords

gastrointestinal haemorrhagestomach ulceranti-inflammatory agents, non-steroidalCYP2C9 protein, humangenotypepharmacogenetics

Interventions

CY2PC9 genotypingPROCEDURE

CY2PC9 genotyping

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inclusion Criteria: * Upper gastrointestinal bleeding revealed by hematemesis, melena or lowering of at least 2g/dl of haemoglobin * Endoscopic report of gastrointestinal ulcer or haemorrhagic lesion * Immediate antecedents of NSAID therapy Exclusion Criteria: * Cirrhosis (Child B or C) * Coma * Concomitant therapy with substrates or inhibitors of CYP2C9 : ketoconazole, itraconazole, ritonavir, phenobarbital, rifampicin, depakine, phenytoin, St John's worts * Patients treated by a NSAID metabolized by CYP2C9 and a NSAID not metabolized by CYP2C9

You may qualify if:

  • Upper gastrointestinal bleeding revealed by hematemesis, melena or lowering of at least 2g/dl of haemoglobin
  • Endoscopic report of gastrointestinal ulcer or haemorrhagic lesion
  • Immediate antecedents of NSAID therapy

You may not qualify if:

  • Cirrhosis (Child B or C)
  • Coma
  • Concomitant therapy with substrates or inhibitors of CYP2C9 : ketoconazole, itraconazole, ritonavir, phenobarbital, rifampicin, depakine, phenytoin, St John's worts
  • Patients treated by a NSAID metabolized by CYP2C9 and a NSAID not metabolized by CYP2C9

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Service d'hépato-gastroentérologie, Hôpital Saint Antoine

Paris, 75012, France

Location

Service d'hépato-gastroentérologie, Hôpital Pitié Salpétrière

Paris, 75013, France

Location

: Service d'hépato-gastroentérologie, Hôpital Henri Mondor

Paris, 94010, France

Location

Service d'hépato-gastroentérologie, Hôpital Paul BROUSSE

Villejuif, 94804, France

Location

Related Publications (2)

  • Martin JH, Begg EJ, Kennedy MA, Roberts R, Barclay ML. Is cytochrome P450 2C9 genotype associated with NSAID gastric ulceration? Br J Clin Pharmacol. 2001 Jun;51(6):627-30. doi: 10.1046/j.0306-5251.2001.01398.x.

    PMID: 11422024BACKGROUND

  • Martinez C, Blanco G, Ladero JM, Garcia-Martin E, Taxonera C, Gamito FG, Diaz-Rubio M, Agundez JA. Genetic predisposition to acute gastrointestinal bleeding after NSAIDs use. Br J Pharmacol. 2004 Jan;141(2):205-8. doi: 10.1038/sj.bjp.0705623. Epub 2004 Jan 5.

    PMID: 14707031BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Gastrointestinal bleeding is a severe adverse effect occurring in subjects secondary to the use of nonsteroidal anti-inflammatory drugs (NSAIDs). The enzyme CYP2C9 is responsible for the elimination of several NSAIDs. This protein is inactive in 12% of the subjects because of genetic mutations. We hypothesized that individuals carrying such mutations should be at higher risk of gastrointestinal bleeding since they display decreased NSAIDs elimination.

MeSH Terms

Conditions

Gastrointestinal HemorrhageStomach Ulcer

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPeptic UlcerDuodenal DiseasesIntestinal DiseasesStomach Diseases

Study Officials

  • Nicolas CARBONNELL, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • Laurent BECQUEMONT, MD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

April 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

May 10, 2011

Record last verified: 2007-03

Locations

FR(4)