Carcinoma ProstatePhase 2NCT01939743
Efficacy of Diclofenac Suppository for Pain Control in Ultrasound Guided Biopsy of Prostate
A Phase 2 study testing Diclofenac suppository plus lidocaine gel and Lidocaine gel only in people with Carcinoma Prostate, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Transrectal ultrasound guided biopsy of prostate (TRUS-Bx) is widely used as accepted mode of investigation for prostate cancer in current urology practice. It is considered a minor procedure, which most of the patients tolerate, however 20% of patients refuse to undergo the redo procedure without any analgesia or… Read more about this study
- Who is it for?
- Ages 51 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Carcinoma Prostate
- What is being tested?
- Diclofenac suppository plus lidocaine gel and Lidocaine gel only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2011to Oct 2012
- Phase
- Phase 2
- 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 51 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- History of previous prostate biopsy
- Acute and/or chronic prostatitis or chronic pelvic pain syndrome
- Anal fissure, hemorrhoids, anal surgery
- Concomitant analgesic medication
- Chronic renal failure
- Allergy to diclofenac
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diclofenac Suppository As a Preemptive Analgesia in Ultrasound Guided Biopsy of Prostate: Randomized Controlled Trial
Transrectal ultrasound guided biopsy of prostate (TRUS-Bx) is widely used as accepted mode of investigation for prostate cancer in current urology practice. It is considered a minor procedure, which most of the patients tolerate, however 20% of patients refuse to undergo the redo procedure without any analgesia or anesthesia but on the other hand, some authors reveal that 65 to 90% of patients report pain ranging from mild to severe in intensity. Diclofenac is a local and systemic anti-inflammatory drug and it reduces local mediators involved in local pain.The purpose of this study is to find out the role of rectal administration of diclofenac suppositories as an adjunct to 2% xylocaine gel in alleviating intra and post procedural pain in prostatic biopsy with adequately calculated sample size and excluding the patients with contraindication to procedure or diclofenac administration as these were the shortcomings of previous studies.
- Conditions
- Carcinoma Prostate
- Being tested
- Diclofenac suppository plus lidocaine gel, Lidocaine gel only
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac suppository plus lidocaine gelDrug
Also called Voltral suppository
Lidocaine gel onlyDrug
| Study group | Role | What they receive |
|---|---|---|
| diclofenac suppository plus lidocaine gel | Experimental | Intervention Drug with local anaesthetic Receives: Drug: Diclofenac suppository plus lidocaine gel; Drug: Lidocaine gel only |
| Lidocaine gel only | Other | Used as local aneaethetic as a part of institutional prostate biopsy protocol Receives: Drug: Lidocaine gel only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on visual analog score
Measured: Two hours
Secondary outcomes (1)
Adverse effects of diclofenac suppository
Measured: two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startOct 2011
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carcinoma ProstateStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naveed Haroon, Aga Khan University
- Investigators
- Naveed Haroon, MBBS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939743
- Sponsor's protocol ID
- 11GS009SUR
- Status last verified
- Sep 2013
- First submitted
- 1 Apr 2013
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Irer B, Gulcu A, Aslan G, Goktay Y, Celebi I. Diclofenac suppository administration in conjunction with lidocaine gel during transrectal ultrasound-guided prostate biopsy: prospective, randomized, placebo-controlled study. Urology. 2005 Oct;66(4):799-802. doi: 10.1016/j.urology.2005.04.053.
PubMed 16230141Haq A, Patel HR, Habib MR, Donaldson PJ, Parry JR. Diclofenac suppository analgesia for transrectal ultrasound guided biopsies of the prostate: a double-blind, randomized controlled trial. J Urol. 2004 Apr;171(4):1489-91. doi: 10.1097/01.ju.0000115706.19605.e4.
PubMed 15017205
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diclofenac Suppository As a Preemptive Analgesia in Ultrasound Guided Biopsy of Prostate: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01939743
- Acronym / sponsor ID
- 11GS009SUR
- Conditions
- Carcinoma Prostate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 11 Sep 2013 (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.
Transrectal ultrasound guided biopsy of prostate (TRUS-Bx) is widely used as accepted mode of investigation for prostate cancer in current urology practice. It is considered a minor procedure, which most of the patients tolerate, however 20% of patients refuse to undergo the redo procedure without any analgesia or anesthesia but on the other hand, some authors reveal that 65 to 90% of patients report pain ranging from mild to severe in intensity. Diclofenac is a local and systemic anti-inflammatory drug and it reduces local mediators involved in local pain.The purpose of this study is to find out the role of rectal administration of diclofenac suppositories as an adjunct to 2% xylocaine gel in alleviating intra and post procedural pain in prostatic biopsy with adequately calculated sample size and excluding the patients with contraindication to procedure or diclofenac administration as these were the shortcomings of previous studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diclofenac suppository plus lidocaine gel | Experimental | Drug: Diclofenac suppository plus lidocaine gel, Drug: Lidocaine gel onlyIntervention Drug with local anaesthetic |
| Lidocaine gel only | Other | Drug: Lidocaine gel onlyUsed as local aneaethetic as a part of institutional prostate biopsy protocol |
Who may qualify
- Ages
- 51 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- History of previous prostate biopsy
- Acute and/or chronic prostatitis or chronic pelvic pain syndrome
- Anal fissure, hemorrhoids, anal surgery
- Concomitant analgesic medication
- Chronic renal failure
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 suppository plus lidocaine gelAlso: Voltral suppository | Drug | diclofenac suppository plus lidocaine gel |
| Lidocaine gel only | Drug | Lidocaine gel only, diclofenac suppository plus lidocaine gel |
Primary outcome
Pain on visual analog score
Time frame: Two hours
1 secondary outcome
Adverse effects of diclofenac suppository
Time frame: two hours
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 11 Sep 2013.
- Background: PubMed 16230141Irer B, Gulcu A, Aslan G, Goktay Y, Celebi I. Diclofenac suppository administration in conjunction with lidocaine gel during transrectal ultrasound-guided prostate biopsy: prospective, randomized, placebo-controlled study. Urology. 2005 Oct;66(4):799-802. doi: 10.1016/j.urology.2005.04.053.
- Background: PubMed 15017205Haq A, Patel HR, Habib MR, Donaldson PJ, Parry JR. Diclofenac suppository analgesia for transrectal ultrasound guided biopsies of the prostate: a double-blind, randomized controlled trial. J Urol. 2004 Apr;171(4):1489-91. doi: 10.1097/01.ju.0000115706.19605.e4.
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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.
Naveed Haroon, MBBS principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diclofenac suppository plus lidocaine gel and Lidocaine gel only in people with Carcinoma Prostate, run by Aga Khan University at 1 site in Pakistan.
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 0 inclusion and 6 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 11 Sep 2013. 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 Pakistan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pain on visual analog score (time frame: Two hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01939743, which also lists 2 linked publications.
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 11 Sep 2013.