PainPhase 4NCT00893100
Evaluation of Pain Reduction After Hemorrhoidectomy With Use of Diltiazim Ointment 2%
A Phase 4 study testing Diltiazem in people with Pain, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to evaluate the effectiveness of diltiazem ointment 2 percent in reducing pain after hemorrhoidectomy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Diltiazem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteIran
- Study dates
- Oct 2007to Dec 2008
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with grade 3 or 4 hemorrhoid who underwent Milligan-Morgan surgery.
Who cannot join
- Patients with a history of heart disease, blood pressure, orthostatic hypertension, hemorrhoidal surgery,or those who had previous adverse effect from calcium channel blocker drugs and also those who were pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effectiveness of diltiazem ointment 2 percent in reducing pain after hemorrhoidectomy.
Read the detailed description
Pain after hemorrhoidectomy remains a major postsurgical complication.Therefore pain management in patients is an important goal.Many studies have focused on surgical techniques,preoperative and postoperative regimes.We assessed a randomised double blind placebo-controlled trial to evaluate the effect of diltiazem ointment after surgery.
- Conditions
- Pain
- Being tested
- Diltiazem
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiltiazemDrug
2%,3 times daily
| Study group | Role | What they receive |
|---|---|---|
| Diltiazem | Experimental | Not described Receives: Drug: Diltiazem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Pain
Measured: daily in one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startOct 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Farshad Jalili, Resident, Principal investigator, Sina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893100
- Sponsor's protocol ID
- 724
- Status last verified
- May 2009
- First submitted
- 19 Apr 2009
- Last updated
- 5 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain Reduction After Hemorrhoidectomy With Use of Diltiazim Ointment 2%
- ClinicalTrials.gov ID
- NCT00893100
- Acronym / sponsor ID
- 724
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 May 2009 (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 purpose of this study is to evaluate the effectiveness of diltiazem ointment 2 percent in reducing pain after hemorrhoidectomy.
Detailed description
Pain after hemorrhoidectomy remains a major postsurgical complication.Therefore pain management in patients is an important goal.Many studies have focused on surgical techniques,preoperative and postoperative regimes.We assessed a randomised double blind placebo-controlled trial to evaluate the effect of diltiazem ointment after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diltiazem | Experimental | Drug: Diltiazem |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with grade 3 or 4 hemorrhoid who underwent Milligan-Morgan surgery.
Key exclusion criteria (1 listed)
- Patients with a history of heart disease, blood pressure, orthostatic hypertension, hemorrhoidal surgery,or those who had previous adverse effect from calcium channel blocker drugs and also those who were 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 |
|---|---|---|
| Diltiazem2%,3 times daily | Drug | Diltiazem |
Primary outcome
Reduction of Pain
Time frame: daily in one week
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 May 2009.
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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.
Farshad Jalili, Resident principal investigator
Sina Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diltiazem in people with Pain, run by Tehran University of Medical Sciences at 1 site in Iran.
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 5 May 2009. 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 Iran. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Reduction of Pain (time frame: daily in one week). 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 May 2009.