EndoscopyPhase 2/3NCT02714699
Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium Before Office Hysteroscopy
A Phase 2/3 study testing diclofenac potassium and hyoscine butyl bromide in people with Endoscopy, run by Assiut University at 1 site in Egypt.
Trial summary
The study aims to determine the efficacy of oral hyoscine butyl bromide versus diclofenac potassium on the pain scores during office hysteroscopy Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Endoscopy
- What is being tested?
- diclofenac potassium and hyoscine butyl bromide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2016to May 2017
- Phase
- Phase 2/3
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hypersensitivity to drugs
- refusal of the patient
- Patients are pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial of Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium in Reducing Pain During Office Hysteroscopy
The study aims to determine the efficacy of oral hyoscine butyl bromide versus diclofenac potassium on the pain scores during office hysteroscopy
- Conditions
- Endoscopy
- Being tested
- diclofenac potassium, hyoscine butyl bromide, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diclofenac potassiumDrug
Also called cataflam
patients will take oral diclofenac potassium; two tablets (cataflam 25 mg) and one tablet placebo one hour before the procedure
hyoscine butyl bromideDrug
Also called buscopan
patients will take oral hyoscine-N- butyl bromide; 2 tablets (buscopan 10 mg) one hour before the procedure
placeboDrug
patients will take oral placebo; 2 tablets one hour before the procedure
| Study group | Role | What they receive |
|---|---|---|
| diclofenac potassium | Experimental | oral diclofenac potassium Receives: Drug: diclofenac potassium |
| hyoscine butyl bromide | Active comparator | oral hyoscine butyl bromide Receives: Drug: hyoscine butyl bromide |
| placebo | Placebo comparator | oral placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain score during hysteroscopy
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndoscopyStudies of the same condition, open and under way.
- More trials run by Assiut 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714699
- Sponsor's protocol ID
- HB-OH
- Status last verified
- Jan 2018
- First submitted
- 16 Mar 2016
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium in Reducing Pain During Office Hysteroscopy
- ClinicalTrials.gov ID
- NCT02714699
- Acronym / sponsor ID
- HB-OH
- Conditions
- Endoscopy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 21 Mar 2016 (estimated)
- 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.
The study aims to determine the efficacy of oral hyoscine butyl bromide versus diclofenac potassium on the pain scores during office hysteroscopy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| diclofenac potassium | Experimental | Drug: diclofenac potassiumoral diclofenac potassium |
| hyoscine butyl bromide | Active comparator | Drug: hyoscine butyl bromideoral hyoscine butyl bromide |
| placebo | Placebo comparator | Drug: placebooral placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Hypersensitivity to drugs
- refusal of the patient
- Patients are pregnant.
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 |
|---|---|---|
| diclofenac potassiumAlso: cataflampatients will take oral diclofenac potassium; two tablets (cataflam 25 mg) and one tablet placebo one hour before the procedure | Drug | diclofenac potassium |
| hyoscine butyl bromideAlso: buscopanpatients will take oral hyoscine-N- butyl bromide; 2 tablets (buscopan 10 mg) one hour before the procedure | Drug | hyoscine butyl bromide |
| placebopatients will take oral placebo; 2 tablets one hour before the procedure | Drug | placebo |
Primary outcome
Mean pain score during hysteroscopy
Time frame: intraoperative
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 5 Jan 2018.
- Individual participant dataSharing planned: Yes
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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 2/3 study testing diclofenac potassium and hyoscine butyl bromide in people with Endoscopy, run by Assiut 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 5 inclusion and 3 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 5 Jan 2018. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Mean pain score during hysteroscopy (time frame: intraoperative). 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 5 Jan 2018.