Celecoxib in Colposcopic Directed Biopsy

Phase 4

Completed

• Conditions: Colposcopy
• Interventions: Drug: Celecoxib 200mg; Procedure: Colposcopic guided biopsy; Drug: Placebo oral capsule

• Registration Number: NCT03464552
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-14
• Study Start: 2018-04-15
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-25
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 170

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celecoxib group	Celecoxib 200mg	will receive oral Celecoxib 200 mg capsule (Celebrex®200, Pfizer, USA) once 3 hours before the colposcopic guided biopsy
Celecoxib group	Colposcopic guided biopsy	will receive oral Celecoxib 200 mg capsule (Celebrex®200, Pfizer, USA) once 3 hours before the colposcopic guided biopsy
Placebo group	Colposcopic guided biopsy	will receive oral placebo capsule once 3 hours before the colposcopic guided biopsy
Placebo group	Placebo oral capsule	will receive oral placebo capsule once 3 hours before the colposcopic guided biopsy

Primary Outcome Measures

Name	Time	Method
Pain during the procedure	Immediately after the first biopsy	Visual analog score in mm on a 10 cm ruler

Secondary Outcome Measures

Name	Time	Method
Post-procedure pain	At 30 minutes after completing the procedure	Visual analog score in mm on a 10 cm ruler
Pain at time of vaginal speculum application	At time of introduction of vaginal speculum	Visual analog score in mm on a 10 cm ruler

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt