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Celecoxib in Colposcopic Directed Biopsy

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ClinicalTrials.gov Identifier: NCT03464552
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed AA Wali, MD, Cairo University

Brief Summary:

Women often experience pain and discomfort during colposcopic examination especially at time of colposcopic directed excisional biopsy, pre-procedure anxiety, women pain threshold may also increase pain, woman's cooperation during the procedure is affected by all these factors, which also may hinder the colposcopist from obtaining adequate data and biopsies.

Several pharmacological and non-pharmacological methods have been studied to reduce pain associated colposcopic directed biopsy (CDB). We aim to study the effect of Celecoxib to reduce pain associated with CDB.


Condition or disease Intervention/treatment Phase
Colposcopy Drug: Celecoxib 200mg Procedure: Colposcopic guided biopsy Drug: Placebo oral capsule Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Role of Oral Celecoxib 200 mg in Reducing Pain Associated With Colposcopic Directed Biopsy: A Randomized Triple-blind Placebo-controlled Trial
Actual Study Start Date : April 15, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
Drug Information available for: Celecoxib

Arm Intervention/treatment
Active Comparator: Celecoxib group
will receive oral Celecoxib 200 mg capsule (Celebrex®200, Pfizer, USA) once 3 hours before the colposcopic guided biopsy
Drug: Celecoxib 200mg
oral capsule 3 hours before procedure
Other Name: celebrex 200

Procedure: Colposcopic guided biopsy
Patient is placed in the lithotomy position. Vulva is examined for any suspicious lesions. A sterile bivalve speculum is introduced into the vagina to inspect cervix. A 3% acetic acid solution is applied to the cervix to map acetowhite areas for colposcopic directed punch biopsy using Tischler punch forceps.

Placebo Comparator: Placebo group
will receive oral placebo capsule once 3 hours before the colposcopic guided biopsy
Procedure: Colposcopic guided biopsy
Patient is placed in the lithotomy position. Vulva is examined for any suspicious lesions. A sterile bivalve speculum is introduced into the vagina to inspect cervix. A 3% acetic acid solution is applied to the cervix to map acetowhite areas for colposcopic directed punch biopsy using Tischler punch forceps.

Drug: Placebo oral capsule
oral capsule 3 hours before procedure




Primary Outcome Measures :
  1. Pain during the procedure [ Time Frame: Immediately after the first biopsy ]
    Visual analog score in mm on a 10 cm ruler


Secondary Outcome Measures :
  1. Pain at time of vaginal speculum application [ Time Frame: At time of introduction of vaginal speculum ]
    Visual analog score in mm on a 10 cm ruler

  2. Post-procedure pain [ Time Frame: At 30 minutes after completing the procedure ]
    Visual analog score in mm on a 10 cm ruler


Other Outcome Measures:
  1. Effect of pain score on duration of the colposcopic procure [ Time Frame: At time of removal of vaginal speculum ]
    Duration in minutes (from introduction of vaginal speculum till its removal)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Females 18-65 years old who undergoing colposcopic directed biopsy

Exclusion Criteria:

  • A known allergy to Celecoxib, aspirin or another NSAID.
  • Active peptic ulceration or gastrointestinal bleeding.
  • Inflammatory bowel disease.
  • Congestive heart failure (NYHA II-IV).
  • Established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
  • History of neurologic deficit.
  • Known hepatic or renal impairment.
  • Pregnancy.
  • Breast-feeding.
  • Post-hysterectomy.
  • Bleeding disorders.
  • Drug abuse.
  • Cervical and vaginal infection.

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): NCT03464552


Contacts
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Contact: Ahmed AA Wali, MD 01001735088 ext +2 ahmed.wali@kasralainy.edu.eg

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt, 11562
Contact: Ahmed AA Wali, MD    01001735088 ext +2    ahmed.wali@kasralainy.edu.eg   
Principal Investigator: Ahmed AA Wali, MD         
Sponsors and Collaborators
Cairo University

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Responsible Party: Ahmed AA Wali, MD, Lecturer of Obstetrics and Gynecology, Cairo University
ClinicalTrials.gov Identifier: NCT03464552     History of Changes
Other Study ID Numbers: N-2aa6-2018
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Ahmed AA Wali, MD, Cairo University:
colposcopy - colposcopic directed biopsy - celecoxib
Additional relevant MeSH terms:
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Celecoxib
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 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action