Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00190255
Other study ID # P030412
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated May 9, 2011
Start date April 2004
Est. completion date July 2007

Study information

Verified date March 2007
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial 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.


Description:

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 most NSAIDs. Several polymorphisms have been observed in CYP2C9. Of these, the CYP2C9*3 allele, found in 12% of caucasian subjects, leads to reduced function of the enzyme.

We hypothesized that individuals carrying this mutation should be at higher risk of gastrointestinal bleeding since they display decreased elimination of some NSAIDs.

The purpose of this study is to determine whether the frequency for CYP2C9*3 variant allele is increased in subjects using NSAIDs metabolized by CYP2C9 in comparison with subjects under NSAIDs not metabolized by this enzyme.

The study groups consist of 200 patients suffering from gastrointestinal bleeding after NSAIDs use, divided in 100 patients using NSAIDs metabolized by CYP2C9 and 100 patients using other NSAIDs.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
CY2PC9 genotyping
CY2PC9 genotyping

Locations

Country Name City State
France : Service d'hépato-gastroentérologie, Hôpital Henri Mondor Paris
France Service d'hépato-gastroentérologie, Hôpital Pitié Salpétrière Paris
France Service d'hépato-gastroentérologie, Hôpital Saint Antoine Paris
France Service d'hépato-gastroentérologie, Hôpital Paul BROUSSE Villejuif

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Martínez C, Blanco G, Ladero JM, García-Martín E, Taxonera C, Gamito FG, Diaz-Rubio M, Agúndez JA. Genetic predisposition to acute gastrointestinal bleeding after NSAIDs use. Br J Pharmacol. 2004 Jan;141(2):205-8. Epub 2004 Jan 5. — View Citation

See also
  Status Clinical Trial Phase
Completed NCT02903017 - Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage Phase 4
Recruiting NCT02514304 - Study of the Risk Factors and Outcomes After Gastrointestinal Bleeding
Completed NCT02384122 - Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias Phase 3
Completed NCT01477320 - Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients. N/A
Not yet recruiting NCT01549418 - The Risk of Bleeding After Removal of Large Colorectal Polyps in Patients Taking Aspirin Phase 4
Completed NCT02105532 - Transfusion in Gastrointestinal Bleeding Phase 2/Phase 3
Recruiting NCT05226221 - Gastrointestinal Emergency Surgery: Evaluation of Morbidity and Mortality
Active, not recruiting NCT02874326 - Octreotide in Patients With GI Bleeding Due to Rendu-Osler-Weber Phase 2
Completed NCT02928939 - Therapeutic Conflicts and Multimorbidity
Withdrawn NCT01215058 - Gastroprotective Agent Compliance in Patients at Risk Suffering From a Gastrointestinal(GI) Ulcer N/A
Completed NCT01029626 - Glasgow-Blatschford Score Validation in Digestive Hemorrhage N/A
Completed NCT00251979 - A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer Phase 3
Completed NCT02991612 - Rifaximin in Patients With Gastroesophageal Variceal Bleeding N/A
Recruiting NCT02964195 - Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Bleeding N/A
Completed NCT02965209 - European Novel Motorized Spiral Endoscopy Trial N/A
Terminated NCT02609100 - Video Capsule Endoscopy Versus Colonoscopy in Patients With Melena and Negative Upper Endoscopy N/A
Completed NCT01872286 - Comparison of the Frequency-altering AKE-1 Capsule and Pillcam SB2 N/A
Completed NCT02349490 - Seraseal for Endoscopic Hemostasis Phase 4
Withdrawn NCT01005147 - Effect of Tranexamic Acid in Upper Gastrointestinal Bleeding N/A
Completed NCT00570973 - Band Ligation Versus Transjugular Intrahepatic Portosystemic Stent Shunt (TIPS) in Cirrhotics With Recurrent Variceal Bleeding Non Responding to Medical Therapy Phase 4