Diclofenac Potassium Alone Versus Diclofenac Potassium Wi... | NCT04125771

Studies
Diclofenac Potassium Alone Versus Diclofenac Potassium With Hyoscine-N-butyl Bromide (HBB in Endoscopy

NCT04125771

Sponsor

Aljazeera Hospital

Status

Completed

Last Update Posted

Nov 2, 2021Actual

Enrollment

64Actual

Phase

Not Applicable

Conditions

Pain

Interventions

Diclofenac + HBB with hysteroscopy
Diclofenav + placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 16, 2020Actual

Primary Completion Date

Aug 25, 2020Actual

Completion Date

Oct 1, 2020Actual

First Submitted Date

Oct 11, 2019

First Submission Date that Met QC Criteria

Oct 11, 2019

First Posted Date

Oct 14, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2021

Last Update Posted Date

Nov 2, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoud Alalfy, Researcher , lecturer ,Obstetrics and Gynecology , National Research Centre, Aljazeera HospitalPrincipal Investigator

Lead Sponsor

Aljazeera HospitalOTHER

Collaborators

Name	Class
Cairo University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

. As with all NSAIDs, diclofenac exerts its action via inhibition of prostaglandin synthesis by inhibiting cyclooxygenase-1 (COX-1)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diclofenac + HBB	Other	Women who will receive Diclofenac + HBB	Diagnostic Test: Diclofenac + HBB with hysteroscopy Diagnostic Test: Diclofenav + placebo
Diclofenav + placebo	Other	Women who will receive Diclofenav + placebo	Diagnostic Test: Diclofenac + HBB with hysteroscopy Diagnostic Test: Diclofenav + placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diclofenac + HBB with hysteroscopy	Diagnostic Test	Giving Diclofenac + HBB with hysteroscopy	Diclofenac + HBB Diclofenav + placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of women who will not feel pain	the effect of medications on pain sensation	within half an hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

female who will undergo hysteroscopy

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mahmoud Alalfy, PhD	Algezeera hospitaland National Research Centre ,Egypt	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Algazeerah and Kasralainy hospital		Giza			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015907	Hysteroscopy

Ancestor Terms

ID	Term
D003944	Diagnostic Techniques, Obstetrical and Gynecological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004724	Endoscopy

Browse Leaves

Not provided

Browse Branches

Not provided