PainPhase 2DUFNCT01812928

Diclofenac Suppository to Control Pain During Flexible Cystoscopy

A Phase 2 study testing Diclofenac in people with Pain and Hematuria, run by Aga Khan University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Flexible cystoscopy has diagnostic as well as therapeutic role in many patients presenting in urology clinic with lower urinary tract symptoms (frequency, nocturia etc) and hematuria (blood in urine). Read more about this study

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Pain, Hematuria, Lower Urinary Tract Symptoms
What is being tested?: Diclofenac
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 sitePakistan
Study dates: Mar 2013to Aug 2013
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 18 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All male patients aged 18 and above
Visiting for evaluation of Haematuria or
Lower urinary tract symptoms (which include poor steam of urine,intermittency, hesitancy, incomplete voiding of urine, increase urgency, increase frequency, nocturia and urge incontinence)
For removal of double J ureteral stent will be included in the study.

Who cannot join

Patients with clinical evidence of urethral stricture and/or prostatitis,
Patients in which biopsy will be taken,
those having psychiatric illness,
Asthmatics
Kidney, liver disease
Those allergic to NSAIDs (non-steroidal anti-inflammatory drugs)

Show all 9Show fewer

Those who refuse to participate,
Having history of chronic analgesia use or
Having language barrier will be excluded.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Aga Khan University Hospital
Karachi, Sindh, 74800

Other trials in Pakistan

About this study

Official title: Phase 2 Study of Diclofenac Suppository to Control Pain During Flexible Cystoscopy

Pain associated with cystoscopy varies from patient to patient, majority requires local anesthesia or lubricant solution only. During flexible cystoscopy, lubrication, use of topical anesthesia and duration of cystoscopy are recognized as important factors contributing in severity of pain of which use of intraurethral gel left to individual preference. Various studies are available reporting the pain perception with use of various intraurethral gels. Even the highest level of evidence is unable to resolve the query.

With this study the investigators hypothesize that pain perception (recorded in form of pain score) during flexible cystoscopy can be reduced with use of per operative diclofenac(Non Steroidal Anti Inflammatory Drug)suppository in comparison to plain gel alone.

With better control of pain the investigators aim to increase patient comfort and compliance which will increase the patient satisfaction rate and early return to work.

Conditions: Pain, Hematuria, Lower Urinary Tract Symptoms
Being tested: Diclofenac
Keywords: Flexible Cystoscopy, Pain control, Diclofenac, Non steroidal anti inflammatory drug
Medical subject headings: Pain, Hematuria, Lower Urinary Tract Symptoms, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DiclofenacDrug
Also called Non steroidal anti-inflammatory drug

Study groups in NCT01812928
Study group	Role	What they receive
Gel only	No intervention	This group will be given only intraurethral gel during flexible cystoscopy.
Diclofenac and Gel	Experimental	This group will also receive intraurethral gel during cystoscopy but additionally diclofenac suppository will be given per rectally one hour before procedure as preemptive analgesia. Receives: Drug: Diclofenac

What is being measured

The primary outcome is the main question the study is designed to answer.

difference in pain score between two groups
Patient under goes the procedure and with in the operating room the outcome assessor(who will be blinded to randomization) will record the pain score.
Measured: five minutes after procedure

Secondary outcomes (1)

Need of additional analgesia after the procedure
Patient will be assessed for pain during the stay in recovery that usually last for an hour. If there will be need of additional analgesia (if patient reports pain score of more than 7 on visual analogue scale)the type of analgesia, dose and frequency will be noticed.
Measured: with in an hour after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Aug 2013

First posted18 Mar 2013 (estimated)
Study startMar 2013
Primary completionAug 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01812928
Sponsor's protocol ID: 122010SUR
Acronym: DUF
Status last verified: Dec 2013
First submitted: 14 Mar 2013
Last updated: 17 Dec 2013
Results posted: No
Data monitoring committee: Yes

Publications

Kobayashi T, Nishizawa K, Mitsumori K, Ogura K. Instillation of anesthetic gel is no longer necessary in the era of flexible cystoscopy: a crossover study. J Endourol. 2004 Jun;18(5):483-6. doi: 10.1089/0892779041271535.
PubMed 15253827
Goldfischer ER, Cromie WJ, Karrison TG, Naszkiewicz L, Gerber GS. Randomized, prospective, double-blind study of the effects on pain perception of lidocaine jelly versus plain lubricant during outpatient rigid cystoscopy. J Urol. 1997 Jan;157(1):90-4.
PubMed 8976223
Herr HW, Schneider M. Immediate versus delayed outpatient flexible cystoscopy: final report of a randomized study. Can J Urol. 2001 Dec;8(6):1406-8.
PubMed 11788018
Tzortzis V, Gravas S, Melekos MM, de la Rosette JJ. Intraurethral lubricants: a critical literature review and recommendations. J Endourol. 2009 May;23(5):821-6. doi: 10.1089/end.2008.0650.
PubMed 19397430
Aaronson DS, Walsh TJ, Smith JF, Davies BJ, Hsieh MH, Konety BR. Meta-analysis: does lidocaine gel before flexible cystoscopy provide pain relief? BJU Int. 2009 Aug;104(4):506-9; discussion 509-10. doi: 10.1111/j.1464-410X.2009.08417.x. Epub 2009 Feb 23.
PubMed 19239453
Patel AR, Jones JS, Babineau D. Lidocaine 2% gel versus plain lubricating gel for pain reduction during flexible cystoscopy: a meta-analysis of prospective, randomized, controlled trials. J Urol. 2008 Mar;179(3):986-90. doi: 10.1016/j.juro.2007.10.065. Epub 2008 Jan 18.
PubMed 18206920
Komiya A, Endo T, Kobayashi M, Kim W, Araki K, Naya Y, Suzuki H, Tobe T, Ichikawa T, Fuse H. Oral analgesia by non-steroidal anti-inflammatory drug zaltoprofen to manage cystoscopy-related pain: a prospective study. Int J Urol. 2009 Nov;16(11):874-80. doi: 10.1111/j.1442-2042.2009.02384.x. Epub 2009 Sep 24.
PubMed 19780869
Idkaidek NM, Amidon GL, Smith DE, Najib NM, Hassan MM. Determination of the population pharmacokinetic parameters of sustained-release and enteric-coated oral formulations, and the suppository formulation of diclofenac sodium by simultaneous data fitting using NONMEM. Biopharm Drug Dispos. 1998 Apr;19(3):169-74. doi: 10.1002/(sici)1099-081x(199804)19:33.0.co;2-c.
PubMed 9570000

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Study of Diclofenac Suppository to Control Pain During Flexible Cystoscopy
ClinicalTrials.gov ID: NCT01812928
Acronym / sponsor ID: DUF / 122010SUR
Conditions: Pain, Hematuria, Lower Urinary Tract Symptoms
Keywords: Flexible Cystoscopy, Pain control, Diclofenac, Non steroidal anti inflammatory drug
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Aga Khan UniversityUniversity, hospital or other
Study start: Mar 2013
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 18 Mar 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.

With better control of pain the investigators aim to increase patient comfort and compliance which will increase the patient satisfaction rate and early return to work.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Gel only	No intervention	–This group will be given only intraurethral gel during flexible cystoscopy.
Diclofenac and Gel	Experimental	Drug: DiclofenacThis group will also receive intraurethral gel during cystoscopy but additionally diclofenac suppository will be given per rectally one hour before procedure as preemptive analgesia.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

All male patients aged 18 and above
Visiting for evaluation of Haematuria or
Lower urinary tract symptoms (which include poor steam of urine,intermittency, hesitancy, incomplete voiding of urine, increase urgency, increase frequency, nocturia and urge incontinence)
For removal of double J ureteral stent will be included in the study.

Key exclusion criteria (9 listed)

Patients with clinical evidence of urethral stricture and/or prostatitis,
Patients in which biopsy will be taken,
those having psychiatric illness,
Asthmatics
Kidney, liver disease

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
DiclofenacAlso: Non steroidal anti-inflammatory drug	Drug	Diclofenac and Gel

Primary outcome

difference in pain score between two groups
Time frame: five minutes after procedure
Patient under goes the procedure and with in the operating room the outcome assessor(who will be blinded to randomization) will record the pain score.

1 secondary outcome

Need of additional analgesia after the procedure
Time frame: with in an hour after procedure

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 17 Dec 2013.
Background: PubMed 15253827Kobayashi T, Nishizawa K, Mitsumori K, Ogura K. Instillation of anesthetic gel is no longer necessary in the era of flexible cystoscopy: a crossover study. J Endourol. 2004 Jun;18(5):483-6. doi: 10.1089/0892779041271535.
Background: PubMed 8976223Goldfischer ER, Cromie WJ, Karrison TG, Naszkiewicz L, Gerber GS. Randomized, prospective, double-blind study of the effects on pain perception of lidocaine jelly versus plain lubricant during outpatient rigid cystoscopy. J Urol. 1997 Jan;157(1):90-4.
Background: PubMed 11788018Herr HW, Schneider M. Immediate versus delayed outpatient flexible cystoscopy: final report of a randomized study. Can J Urol. 2001 Dec;8(6):1406-8.
Background: PubMed 19397430Tzortzis V, Gravas S, Melekos MM, de la Rosette JJ. Intraurethral lubricants: a critical literature review and recommendations. J Endourol. 2009 May;23(5):821-6. doi: 10.1089/end.2008.0650.
Background: PubMed 19239453Aaronson DS, Walsh TJ, Smith JF, Davies BJ, Hsieh MH, Konety BR. Meta-analysis: does lidocaine gel before flexible cystoscopy provide pain relief? BJU Int. 2009 Aug;104(4):506-9; discussion 509-10. doi: 10.1111/j.1464-410X.2009.08417.x. Epub 2009 Feb 23.
Background: PubMed 18206920Patel AR, Jones JS, Babineau D. Lidocaine 2% gel versus plain lubricating gel for pain reduction during flexible cystoscopy: a meta-analysis of prospective, randomized, controlled trials. J Urol. 2008 Mar;179(3):986-90. doi: 10.1016/j.juro.2007.10.065. Epub 2008 Jan 18.
Background: PubMed 19780869Komiya A, Endo T, Kobayashi M, Kim W, Araki K, Naya Y, Suzuki H, Tobe T, Ichikawa T, Fuse H. Oral analgesia by non-steroidal anti-inflammatory drug zaltoprofen to manage cystoscopy-related pain: a prospective study. Int J Urol. 2009 Nov;16(11):874-80. doi: 10.1111/j.1442-2042.2009.02384.x. Epub 2009 Sep 24.
Background: PubMed 9570000Idkaidek NM, Amidon GL, Smith DE, Najib NM, Hassan MM. Determination of the population pharmacokinetic parameters of sustained-release and enteric-coated oral formulations, and the suppository formulation of diclofenac sodium by simultaneous data fitting using NONMEM. Biopharm Drug Dispos. 1998 Apr;19(3):169-74. doi: 10.1002/(sici)1099-081x(199804)19:33.0.co;2-c.

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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.

mehwash nadeem, M.B.,B,S 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 in people with Pain and Hematuria, 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 4 inclusion and 9 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 17 Dec 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?

difference in pain score between two groups (time frame: five minutes after procedure). 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 NCT01812928, which also lists 8 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 17 Dec 2013.