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

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ClinicalTrials.gov Identifier: NCT00442676

Recruitment Status : Withdrawn (No patients were recruited. Treatment drug expired.)

First Posted : March 2, 2007

Last Update Posted : March 13, 2012

Sponsor:

Information provided by (Responsible Party):

Virginia Commonwealth University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Preeclampsia	Drug: Celecoxib Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Clinical Trial of a COX-2 Inhibitor for the Treatment of Women With Preeclampsia
Study Start Date :	June 2009
Actual Primary Completion Date :	January 2010
Actual Study Completion Date :	January 2010

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Hypertension Preeclampsia

Drug Information available for: Celecoxib

Genetic and Rare Diseases Information Center resources: Eclampsia

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1 Celecoxib, 200 mg/day	Drug: Celecoxib Capsule, 200 mg/day until 32 weeks of gestation Other Name: Celebrex
Placebo Comparator: 2 Placebo	Drug: Placebo Gelatin capsules of lactose

Outcome Measures

Primary Outcome Measures :

Length from start of treatment to delivery [ Time Frame: From start of treatment to delivery ]

Secondary Outcome Measures :

Prevalence of severe preeclampsia [ Time Frame: From start of treatment to delivery ]
Blood pressure [ Time Frame: From start of treatment to delivery ]
Proteinuria [ Time Frame: From start of treatment to delivery ]
Maternal complications [ Time Frame: From start of treatment to delivery ]
Fetal/neonatal status [ Time Frame: From start of treatment to delivery ]
Gestational age at delivery [ Time Frame: At time of delivery ]
Birth weight [ Time Frame: At time of delivery ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00442676

Locations

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United States, Virginia
MCV Main Hospital
Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

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Principal Investigator:	Scott W Walsh, PhD	Virginia Commonwealth University
Study Director:	Susan M Lanni, MD	Virginia Commonwealth University
Study Director:	Fidelma B Rigby, MD	Virginia Commonwealth University
Study Director:	Nicole W Karjane, MD	Virginia Commonwealth University

More Information

Publications:

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.

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.

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.

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Responsible Party:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00442676 History of Changes
Other Study ID Numbers:	VCU IRB HM10590
First Posted:	March 2, 2007 Key Record Dates
Last Update Posted:	March 13, 2012
Last Verified:	March 2012

Additional relevant MeSH terms:

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Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Celecoxib Cyclooxygenase 2 Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics	Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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