ColposcopyPhase 4NCT03464552
Celecoxib in Colposcopic Directed Biopsy
A Phase 4 study testing Celecoxib 200mg and Colposcopic guided biopsy in people with Colposcopy, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Colposcopy
- What is being tested?
- Celecoxib 200mg and Colposcopic guided biopsy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2018to 30 Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females 18-65 years old who undergoing colposcopic directed biopsy
Who cannot join
- 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.
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- Known hepatic or renal impairment.
- Pregnancy.
- Breast-feeding.
- Post-hysterectomy.
- Bleeding disorders.
- Drug abuse.
- Cervical and vaginal infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Oral Celecoxib 200 mg in Reducing Pain Associated With Colposcopic Directed Biopsy: A Randomized Triple-blind Placebo-controlled Trial
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
- Being tested
- Celecoxib 200mg, Colposcopic guided biopsy, Placebo oral capsule
- Keywords
- colposcopy - colposcopic directed biopsy - celecoxib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celecoxib 200mgDrug
Also called celebrex 200
oral capsule 3 hours before procedure
Colposcopic guided biopsyProcedure or surgery
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 capsuleDrug
oral capsule 3 hours before procedure
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib group | Active comparator | will receive oral Celecoxib 200 mg capsule (Celebrex®200, Pfizer, USA) once 3 hours before the colposcopic guided biopsy Receives: Drug: Celecoxib 200mg; Procedure: Colposcopic guided biopsy |
| Placebo group | Placebo comparator | will receive oral placebo capsule once 3 hours before the colposcopic guided biopsy Receives: Procedure: Colposcopic guided biopsy; Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during the procedure
Visual analog score in mm on a 10 cm ruler
Measured: Immediately after the first biopsy
Secondary outcomes (2)
Pain at time of vaginal speculum application
Visual analog score in mm on a 10 cm ruler
Measured: At time of introduction of vaginal speculum
Post-procedure pain
Visual analog score in mm on a 10 cm ruler
Measured: At 30 minutes after completing the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start15 Apr 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColposcopyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed AA Wali, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464552
- Sponsor's protocol ID
- N-2aa6-2018
- Status last verified
- Oct 2020
- First submitted
- 2 Mar 2018
- Last updated
- 27 Oct 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Oral Celecoxib 200 mg in Reducing Pain Associated With Colposcopic Directed Biopsy: A Randomized Triple-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03464552
- Acronym / sponsor ID
- N-2aa6-2018
- Conditions
- Colposcopy
- Keywords
- colposcopy - colposcopic directed biopsy - celecoxib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celecoxib group | Active comparator | Drug: Celecoxib 200mg, Procedure: Colposcopic guided biopsywill receive oral Celecoxib 200 mg capsule (Celebrex®200, Pfizer, USA) once 3 hours before the colposcopic guided biopsy |
| Placebo group | Placebo comparator | Procedure: Colposcopic guided biopsy, Drug: Placebo oral capsulewill receive oral placebo capsule once 3 hours before the colposcopic guided biopsy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Females 18-65 years old who undergoing colposcopic directed biopsy
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celecoxib 200mgAlso: celebrex 200oral capsule 3 hours before procedure | Drug | Celecoxib group |
| Colposcopic guided biopsyPatient 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. | Procedure or surgery | Celecoxib group, Placebo group |
| Placebo oral capsuleoral capsule 3 hours before procedure | Drug | Placebo group |
Primary outcome
Pain during the procedure
Time frame: Immediately after the first biopsy
Visual analog score in mm on a 10 cm ruler
2 secondary outcomes
Pain at time of vaginal speculum application
Time frame: At time of introduction of vaginal speculum
Post-procedure pain
Time frame: At 30 minutes after completing the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Celecoxib 200mg and Colposcopic guided biopsy in people with Colposcopy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during the procedure (time frame: Immediately after the first biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.