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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

Tracking Information
First Submitted Date  ICMJE March 2, 2018
First Posted Date  ICMJE March 14, 2018
Last Update Posted Date January 18, 2019
Actual Study Start Date  ICMJE April 15, 2018
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2018)
Pain during the procedure [ Time Frame: Immediately after the first biopsy ]
Visual analog score in mm on a 10 cm ruler
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03464552 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2018)
  • 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
  • Post-procedure pain [ Time Frame: At 30 minutes after completing the procedure ]
    Visual analog score in mm on a 10 cm ruler
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 7, 2018)
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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Celecoxib in Colposcopic Directed Biopsy
Official Title  ICMJE Role of Oral Celecoxib 200 mg in Reducing Pain Associated With Colposcopic Directed Biopsy: A Randomized Triple-blind Placebo-controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Colposcopy
Intervention  ICMJE
  • 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.
  • Drug: Placebo oral capsule
    oral capsule 3 hours before procedure
Study Arms  ICMJE
  • Active Comparator: Celecoxib group
    will receive oral Celecoxib 200 mg capsule (Celebrex®200, Pfizer, USA) once 3 hours before the colposcopic guided biopsy
    Interventions:
    • Drug: Celecoxib 200mg
    • Procedure: Colposcopic guided biopsy
  • Placebo Comparator: Placebo group
    will receive oral placebo capsule once 3 hours before the colposcopic guided biopsy
    Interventions:
    • Procedure: Colposcopic guided biopsy
    • Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 7, 2018)
170
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ahmed AA Wali, MD 01001735088 ext +2 ahmed.wali@kasralainy.edu.eg
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03464552
Other Study ID Numbers  ICMJE N-2aa6-2018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ahmed AA Wali, MD, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP