Clinical Trial of a COX-2 Inhibitor for the Treatment of Women With Preeclampsia

Preeclampsia Clinical Trial

Official title:

Clinical Trial of a COX-2 Inhibitor for the Treatment of Women With Preeclampsia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00442676
• Other study ID #: VCU IRB HM10590
• Status: Withdrawn
• Phase: Phase 2
• First received: February 28, 2007
• Last updated: March 12, 2012
• Start date: June 2009
• Est. completion date: January 2010

Study information

• Verified date: March 2012
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Preeclampsia is a hypertensive disorder of pregnancy and a leading cause of fetal and maternal morbidity and mortality. Recent findings indicate preeclampsia is an inflammatory disorder associated with increased expression of COX-2. This study will test the hypothesis that treatment of women with a COX-2 inhibitor, celecoxib, will stop the inflammatory process and reverse symptoms of preeclampsia.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Pregnant women with preeclampsia between 20 - 32 weeks gestation. Preeclampsia is defined as a maternal blood pressure of >140/90 mmHg on two readings at least 6 hours apart with proteinuria of >300 mg/24 hours.

Exclusion Criteria:

• Exclusion criteria includes patients with known sensitivity to celecoxib; patients who have demonstrated allergic-type reactions to sulfonamides; patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Other exclusion criteria will include patients with known cardiovascular disease or risk factors for cardiovascular disease, a prior history of ulcer disease or GI bleeding, impaired renal function, or liver dysfunction. Exclusion criteria will also include concomitant use of oral corticosteroids, anticoagulants, diuretics, ACE inhibitors, aspirin, fluconazole, and lithium.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• Celecoxib
Capsule, 200 mg/day until 32 weeks of gestation
• Placebo
Gelatin capsules of lactose

Locations

Country	Name	City	State
United States	MCV Main Hospital	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Groom KM, Shennan AH, Jones BA, Seed P, Bennett PR. TOCOX--a randomised, double-blind, placebo-controlled trial of rofecoxib (a COX-2-specific prostaglandin inhibitor) for the prevention of preterm delivery in women at high risk. BJOG. 2005 Jun;112(6):725-30. — View Citation

Leik CE, Walsh SW. Neutrophils infiltrate resistance-sized vessels of subcutaneous fat in women with preeclampsia. Hypertension. 2004 Jul;44(1):72-7. Epub 2004 May 17. — View Citation

Shah TJ, Walsh SW. Activation of NF-kappaB and expression of COX-2 in association with neutrophil infiltration in systemic vascular tissue of women with preeclampsia. Am J Obstet Gynecol. 2007 Jan;196(1):48.e1-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length from start of treatment to delivery		From start of treatment to delivery	No
Secondary	Prevalence of severe preeclampsia		From start of treatment to delivery	No
Secondary	Blood pressure		From start of treatment to delivery	No
Secondary	Proteinuria		From start of treatment to delivery	No
Secondary	Maternal complications		From start of treatment to delivery	No
Secondary	Fetal/neonatal status		From start of treatment to delivery	No
Secondary	Gestational age at delivery		At time of delivery	No
Secondary	Birth weight		At time of delivery	No