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Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium Before Office Hysteroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714699
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Tracking Information
First Submitted Date  ICMJE March 16, 2016
First Posted Date  ICMJE March 21, 2016
Last Update Posted Date January 5, 2018
Actual Study Start Date  ICMJE October 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
Mean pain score during hysteroscopy [ Time Frame: intraoperative ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium Before Office Hysteroscopy
Official Title  ICMJE Randomized Clinical Trial of Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium in Reducing Pain During Office Hysteroscopy
Brief Summary The study aims to determine the efficacy of oral hyoscine butyl bromide versus diclofenac potassium on the pain scores during office hysteroscopy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Endoscopy
Intervention  ICMJE
  • Drug: diclofenac potassium
    patients will take oral diclofenac potassium; two tablets (cataflam 25 mg) and one tablet placebo one hour before the procedure
    Other Name: cataflam
  • Drug: hyoscine butyl bromide
    patients will take oral hyoscine-N- butyl bromide; 2 tablets (buscopan 10 mg) one hour before the procedure
    Other Name: buscopan
  • Drug: placebo
    patients will take oral placebo; 2 tablets one hour before the procedure
Study Arms  ICMJE
  • Experimental: diclofenac potassium
    oral diclofenac potassium
    Intervention: Drug: diclofenac potassium
  • Active Comparator: hyoscine butyl bromide
    oral hyoscine butyl bromide
    Intervention: Drug: hyoscine butyl bromide
  • Placebo Comparator: placebo
    oral placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2017)
129
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2016)
150
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Hypersensitivity to drugs
  2. refusal of the patient
  3. Patients are pregnant.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02714699
Other Study ID Numbers  ICMJE HB-OH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Ahmed Mohamed Abbas, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP