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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00442676 |
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Date of registration:
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28/02/2007 |
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Primary sponsor: |
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Public title:
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Clinical Trial of a COX-2 Inhibitor for the Treatment of Women With Preeclampsia
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Scientific title:
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Clinical Trial of a COX-2 Inhibitor for the Treatment of Women With Preeclampsia |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT00442676 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Fidelma B Rigby, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Virginia Commonwealth University |
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Name:
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Nicole W Karjane, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Virginia Commonwealth University |
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Name:
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Scott W Walsh, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Virginia Commonwealth University |
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Name:
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Susan M Lanni, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Virginia Commonwealth University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Preeclampsia
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Intervention(s)
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Drug: Celecoxib
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Drug: Placebo
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Primary Outcome(s)
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Length from start of treatment to delivery
[Time Frame: From start of treatment to delivery]
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Secondary Outcome(s)
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Birth weight
[Time Frame: At time of delivery]
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Blood pressure
[Time Frame: From start of treatment to delivery]
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Fetal/neonatal status
[Time Frame: From start of treatment to delivery]
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Gestational age at delivery
[Time Frame: At time of delivery]
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Maternal complications
[Time Frame: From start of treatment to delivery]
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Prevalence of severe preeclampsia
[Time Frame: From start of treatment to delivery]
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Proteinuria
[Time Frame: From start of treatment to delivery]
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Secondary ID(s)
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VCU IRB HM10590
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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