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WithdrawnNCT00442676Updated Mar 13, 2012

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

A Phase 2 interventional study of Celecoxib and Placebo in Preeclampsia, sponsored by Virginia Commonwealth University. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-13.

Sponsored by Virginia Commonwealth University · Phase 2, Interventional, and Treatment

Why this study was withdrawn
No patients were recruited. Treatment drug expired.
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
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Study 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.

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Conditions studied

  • Preeclampsia

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03

In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

Browse Pre-Eclampsia studies →

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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:

  • 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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    1

    Celecoxib, 200 mg/day

    Drug: Celecoxib

  • Placebo comparator
    2

    Placebo

    Drug: Placebo

Interventions

  • DrugCelecoxib

    Capsule, 200 mg/day until 32 weeks of gestation

    Also known as: Celebrex

  • DrugPlacebo

    Gelatin capsules of lactose

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What researchers measure

Primary outcomes

  1. Length from start of treatment to delivery

    Time frame: From start of treatment to delivery

Secondary outcomes

  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

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Study locations

1 site
  • MCV Main Hospital
    Richmond, Virginia 23298, United States
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References and documents

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. doi: 10.1016/j.ajog.2006.08.038. PubMed 17240230 ↗
  • 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. PubMed 15148293 ↗
  • 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. PubMed 15924527 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00442676
Lead sponsor
Virginia Commonwealth University
Responsible party
Sponsor
First posted
Mar 2, 2007
Start date
Jun 2009
Primary completion
Jan 2010
Completion
Jan 2010
Last update
Mar 13, 2012

Study contacts

Scott W Walsh, PhD
principal investigator · Virginia Commonwealth University
Susan M Lanni, MD
study director · Virginia Commonwealth University
Fidelma B Rigby, MD
study director · Virginia Commonwealth University
Nicole W Karjane, MD
study director · Virginia Commonwealth University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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