NCT04125771

Brief Summary

Diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be effective in treating a variety of acute and chronic pain and inflammatory conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

February 16, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

October 11, 2019

Last Update Submit

October 31, 2021

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • The number of women who will not feel pain

    the effect of medications on pain sensation

    within half an hour

Study Arms (2)

Diclofenac + HBB

OTHER

Women who will receive Diclofenac + HBB

Diagnostic Test: Diclofenac + HBB with hysteroscopyDiagnostic Test: Diclofenav + placebo

Diclofenav + placebo

OTHER

Women who will receive Diclofenav + placebo

Diagnostic Test: Diclofenac + HBB with hysteroscopyDiagnostic Test: Diclofenav + placebo

Interventions

Diclofenac + HBB with hysteroscopyDIAGNOSTIC_TEST

Giving Diclofenac + HBB with hysteroscopy

Diclofenac + HBBDiclofenav + placebo
Diclofenav + placeboDIAGNOSTIC_TEST

Giving Diclofenac + placebo with hysteroscopy

Diclofenac + HBBDiclofenav + placebo

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale who will undergo hysteroscopy
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Patients indicated for diagnostic hysteroscopy including infertility, bleeding, suspected intrauterine pathologies (eg polypi , septea) 2. Reproductive age 20 - 40yrs

You may not qualify if:

  • \. Menopausal and amenorrhic patients 2. Contraindication to office hysteroscopy such as:- pelvic inflammatory disease, marked cervical stenosis, pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algazeerah and Kasralainy hospital

Giza, Egypt

Location

MeSH Terms

Conditions

Pain

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Mahmoud Alalfy, PhD

    Algezeera hospitaland National Research Centre ,Egypt

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher , lecturer ,Obstetrics and Gynecology , National Research Centre

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 14, 2019

Study Start

February 16, 2020

Primary Completion

August 25, 2020

Study Completion

October 1, 2020

Last Updated

November 2, 2021

Record last verified: 2021-10

Locations

EG(1)