Back to resultsClinical Trial of a COX-2 Inhibitor for the Treatment of Women With Preeclampsia
Primary Purpose
Preeclampsia
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Celecoxib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Preeclampsia
Eligibility 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.
Sites / Locations
- MCV Main Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Celecoxib, 200 mg/day
Placebo
Outcomes
Primary Outcome Measures
Length from start of treatment to delivery
Secondary Outcome Measures
Prevalence of severe preeclampsia
Blood pressure
Proteinuria
Maternal complications
Fetal/neonatal status
Gestational age at delivery
Birth weight
Full Information
NCT ID
NCT00442676
First Posted
February 28, 2007
Last Updated
March 12, 2012
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT00442676
Brief Title
Clinical Trial of a COX-2 Inhibitor for the Treatment of Women With Preeclampsia
Official Title
Clinical Trial of a COX-2 Inhibitor for the Treatment of Women With Preeclampsia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Withdrawn
Why Stopped
No patients were recruited. Treatment drug expired.
Study Start Date
June 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Celecoxib, 200 mg/day
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
Capsule, 200 mg/day until 32 weeks of gestation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Gelatin capsules of lactose
Primary Outcome Measure Information:
Title
Length from start of treatment to delivery
Time Frame
From start of treatment to delivery
Secondary Outcome Measure Information:
Title
Prevalence of severe preeclampsia
Time Frame
From start of treatment to delivery
Title
Blood pressure
Time Frame
From start of treatment to delivery
Title
Proteinuria
Time Frame
From start of treatment to delivery
Title
Maternal complications
Time Frame
From start of treatment to delivery
Title
Fetal/neonatal status
Time Frame
From start of treatment to delivery
Title
Gestational age at delivery
Time Frame
At time of delivery
Title
Birth weight
Time Frame
At time of delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott W Walsh, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan M Lanni, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fidelma B Rigby, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nicole W Karjane, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Study Director
Facility Information:
Facility Name
MCV Main Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17240230
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. doi: 10.1016/j.ajog.2006.08.038.
Results Reference
background
PubMed Identifier
15148293
Citation
Leik CE, Walsh SW. Neutrophils infiltrate resistance-sized vessels of subcutaneous fat in women with preeclampsia. Hypertension. 2004 Jul;44(1):72-7. doi: 10.1161/01.HYP.0000130483.83154.37. Epub 2004 May 17.
Results Reference
background
PubMed Identifier
15924527
Citation
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. doi: 10.1111/j.1471-0528.2005.00539.x.
Results Reference
background
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Clinical Trial of a COX-2 Inhibitor for the Treatment of Women With Preeclampsia
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