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

Sponsored by:	Virginia Commonwealth University
Information provided by:	Virginia Commonwealth University
ClinicalTrials.gov Identifier:	NCT00442676

Purpose

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	Intervention	Phase
Preeclampsia	Drug: Celecoxib Drug: Placebo	Phase II

Drug Information available for: Celecoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Clinical Trial of a COX-2 Inhibitor for the Treatment of Women With Preeclampsia

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:

Length from start of treatment to delivery [ Time Frame: From start of treatment to delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Prevalence of severe preeclampsia [ Time Frame: From start of treatment to delivery ] [ Designated as safety issue: No ]
Blood pressure [ Time Frame: From start of treatment to delivery ] [ Designated as safety issue: No ]
Proteinuria [ Time Frame: From start of treatment to delivery ] [ Designated as safety issue: No ]
Maternal complications [ Time Frame: From start of treatment to delivery ] [ Designated as safety issue: No ]
Fetal/neonatal status [ Time Frame: From start of treatment to delivery ] [ Designated as safety issue: No ]
Gestational age at delivery [ Time Frame: At time of delivery ] [ Designated as safety issue: No ]
Birth weight [ Time Frame: At time of delivery ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	June 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Celecoxib, 200 mg/day	Drug: Celecoxib Capsule, 200 mg/day until 32 weeks of gestation
2: Placebo Comparator Placebo	Drug: Placebo Gelatin capsules of lactose

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442676

Contacts

Contact: Scott W Walsh, PhD	804-828-8468	swwalsh@vcu.edu
Contact: Susan M Lanni, MD	828-8468	slanni@mcvh-vcu.edu

Locations

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

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

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.

Responsible Party:	Virginia Commonwealth University ( Scott W. Walsh, Ph.D., Professor, Principal Investigator )
Study ID Numbers:	VCU IRB HM10590
Study First Received:	February 28, 2007
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00442676 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Pregnancy Complications
Celecoxib
Eclampsia
Cyclooxygenase Inhibitors
Pre-Eclampsia
Preeclampsia

Cyclooxygenase 2 Inhibitors
Hypertension, Pregnancy-Induced
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Hypertension

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Pregnancy Complications
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Pre-Eclampsia
Enzyme Inhibitors
Cyclooxygenase 2 Inhibitors

Pharmacologic Actions
Hypertension, Pregnancy-Induced
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009