NCT02714699

Brief Summary

The study aims to determine the efficacy of oral hyoscine butyl bromide versus diclofenac potassium on the pain scores during office hysteroscopy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_2

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

March 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 5, 2018

Status Verified

January 1, 2018

Enrollment Period

5 months

First QC Date

March 16, 2016

Last Update Submit

January 4, 2018

Conditions

Endoscopy

Outcome Measures

Primary Outcomes (1)

  • Mean pain score during hysteroscopy

    intraoperative

Study Arms (3)

diclofenac potassium

EXPERIMENTAL

oral diclofenac potassium

Drug: diclofenac potassium

hyoscine butyl bromide

ACTIVE COMPARATOR

oral hyoscine butyl bromide

Drug: hyoscine butyl bromide

placebo

PLACEBO COMPARATOR

oral placebo

Drug: placebo

Interventions

diclofenac potassiumDRUG

patients will take oral diclofenac potassium; two tablets (cataflam 25 mg) and one tablet placebo one hour before the procedure

Also known as: cataflam
diclofenac potassium
hyoscine butyl bromideDRUG

patients will take oral hyoscine-N- butyl bromide; 2 tablets (buscopan 10 mg) one hour before the procedure

Also known as: buscopan
hyoscine butyl bromide
placeboDRUG

patients will take oral placebo; 2 tablets one hour before the procedure

placebo

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients that must perform a diagnostic hysteroscopy.
  • Acceptance to participate in the study.
  • Signed informed consent.
  • Not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) before admission.
  • Absence of sedative use before admission

You may not qualify if:

  • Hypersensitivity to drugs
  • refusal of the patient
  • Patients are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Interventions

DiclofenacButylscopolammonium Bromide

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsQuaternary Ammonium CompoundsAminesScopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 16, 2016

First Posted

March 21, 2016

Study Start

October 1, 2016

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

January 5, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

Locations

EG(1)