MedDataX Logo

Celecoxib in Colposcopic Directed Biopsy

NCT ID: NCT03464552

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-15

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colposcopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Celecoxib group

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

Group Type ACTIVE_COMPARATOR

Celecoxib 200mg

Intervention Type DRUG

oral capsule 3 hours before procedure

Colposcopic guided biopsy

Intervention Type 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.

Placebo group

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

Group Type PLACEBO_COMPARATOR

Colposcopic guided biopsy

Intervention Type 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.

Placebo oral capsule

Intervention Type DRUG

oral capsule 3 hours before procedure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Celecoxib 200mg

oral capsule 3 hours before procedure

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Placebo oral capsule

oral capsule 3 hours before procedure

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

celebrex 200

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed AA Wali, MD

Lecturer of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cairo University

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

N-2aa6-2018

Identifier Type: -

Identifier Source: org_study_id