Celecoxib in Colposcopic Directed Biopsy

NCT03464552 | Completed Phase 4 FDA Drug

• 1 other identifier: N-2aa6-2018
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Colposcopy

Keywords

colposcopy - colposcopic directed biopsy - celecoxib

Outcome Measures

Primary Outcomes (1)

• Pain during the procedure

  Visual analog score in mm on a 10 cm ruler

  Immediately after the first biopsy

Secondary Outcomes (2)

• Pain at time of vaginal speculum application

  At time of introduction of vaginal speculum

• Post-procedure pain

  At 30 minutes after completing the procedure

Other Outcomes (1)

• Effect of pain score on duration of the colposcopic procure

  At time of removal of vaginal speculum

Study Arms (2)

Celecoxib group

ACTIVE COMPARATOR

will receive oral Celecoxib 200 mg capsule (Celebrex®200, Pfizer, USA) once 3 hours before the colposcopic guided biopsy

Drug: Celecoxib 200mg; Procedure: Colposcopic guided biopsy

Placebo group

PLACEBO COMPARATOR

will receive oral placebo capsule once 3 hours before the colposcopic guided biopsy

Procedure: Colposcopic guided biopsy; Drug: Placebo oral capsule

Interventions

Celecoxib 200mg DRUG

oral capsule 3 hours before procedure

Also known as: celebrex 200

Celecoxib group

Colposcopic guided biopsy PROCEDURE

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.

Celecoxib group; Placebo group

Placebo oral capsule DRUG

oral capsule 3 hours before procedure

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11562, Egypt

Location

MeSH Terms

Interventions

Celecoxib

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 14, 2018
• Study Start: April 15, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: October 27, 2020

Record last verified: 2020-10

Locations

EG (1)