Pain Relief With HSGPhase 3DP-LNCT02709590
Diclofenac Potassium With Lidocaine Cream in Reducing Pain During HSG
A Phase 3 study testing diclofenac potassium + lidocaine in people with Pain Relief With HSG, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of our study is to determine the efficacy of oral diclofenac potassium combined with lidocaine cream on the pain scores during HSG. Read more about this study
- Who is it for?
- Ages 19 to 42 years, women only
- Conditions the study is for
- Pain Relief With HSG
- What is being tested?
- diclofenac potassium + lidocaine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2016to Jul 2016
- Phase
- Phase 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 19 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- any patient came for HSG
Who cannot join
- any patient has contraindication to HSG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial of Oral Diclofenac Potassium With Cervical Lidocaine Cream in Reducing Pain During HSG
The aim of our study is to determine the efficacy of oral diclofenac potassium combined with lidocaine cream on the pain scores during HSG.
- Conditions
- Pain Relief With HSG
- Being tested
- diclofenac potassium + lidocaine, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diclofenac potassium + lidocaineDrug
Also called combined therapy
patients will have of oral diclofenac potassium 60 minutes before the procedure plus lidocaine anesthetic cream placed into their cervix immediately before HSG
placeboDrug
patients will have of oral placebo tablet 60 minutes before the procedure plus placebo cream placed into their cervix immediately before HSG
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | oral diclofenac potassium plus lidocaine anesthetic cream placed into their cervix immediately before HSG Receives: Drug: diclofenac potassium + lidocaine |
| Group B | Placebo comparator | oral placebo tablets plus placebo cream placed into their cervix immediately before HSG Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain score during hysterosalpigography by visual analog scale
Measured: intraoperative
Secondary outcomes (2)
Mean pain score after hysterosalpigography
Measured: 30 minutes
side effects of medication
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Relief With HSGStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 140 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
- NCT02709590
- Sponsor's protocol ID
- HS3
- Acronym
- DP-L
- Status last verified
- Apr 2017
- First submitted
- 11 Mar 2016
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Oral Diclofenac Potassium With Cervical Lidocaine Cream in Reducing Pain During HSG
- ClinicalTrials.gov ID
- NCT02709590
- Acronym / sponsor ID
- DP-L / HS3
- Conditions
- Pain Relief With HSG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 16 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 aim of our study is to determine the efficacy of oral diclofenac potassium combined with lidocaine cream on the pain scores during HSG.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: diclofenac potassium + lidocaineoral diclofenac potassium plus lidocaine anesthetic cream placed into their cervix immediately before HSG |
| Group B | Placebo comparator | Drug: placebooral placebo tablets plus placebo cream placed into their cervix immediately before HSG |
Who may qualify
- Ages
- 19 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- any patient came for HSG
Key exclusion criteria (1 listed)
- any patient has contraindication to HSG
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 potassium + lidocaineAlso: combined therapypatients will have of oral diclofenac potassium 60 minutes before the procedure plus lidocaine anesthetic cream placed into their cervix immediately before HSG | Drug | Group A |
| placebopatients will have of oral placebo tablet 60 minutes before the procedure plus placebo cream placed into their cervix immediately before HSG | Drug | Group B |
Primary outcome
Mean pain score during hysterosalpigography by visual analog scale
Time frame: intraoperative
2 secondary outcomes
Mean pain score after hysterosalpigography
Time frame: 30 minutes
side effects of medication
Time frame: 30 minutes
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 26 Apr 2017.
- Individual participant dataSharing planned: Undecided
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 3 study testing diclofenac potassium + lidocaine in people with Pain Relief With HSG, 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 1 inclusion and 1 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 26 Apr 2017. 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 phase mean?
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 hysterosalpigography by visual analog scale (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 26 Apr 2017.