Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 98 of 147 for:    severe preeclampsia AND hypertensive disorders

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (No patients were recruited.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

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

Layout table for study information
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

Drug Information available for: Celecoxib

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




Primary Outcome Measures :
  1. Length from start of treatment to delivery [ Time Frame: From start of treatment to delivery ]

Secondary Outcome Measures :
  1. Prevalence of severe preeclampsia [ Time Frame: From start of treatment to delivery ]
  2. Blood pressure [ Time Frame: From start of treatment to delivery ]
  3. Proteinuria [ Time Frame: From start of treatment to delivery ]
  4. Maternal complications [ Time Frame: From start of treatment to delivery ]
  5. Fetal/neonatal status [ Time Frame: From start of treatment to delivery ]
  6. Gestational age at delivery [ Time Frame: At time of delivery ]
  7. Birth weight [ Time Frame: At time of delivery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Information from the National Library of Medicine

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
Layout table for location information
United States, Virginia
MCV Main Hospital
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Layout table for investigator information
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

Publications:
Layout table for additonal information
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:
Layout table for MeSH terms
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