Renal ColicPhase 3NCT01742689
Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic
A Phase 3 study testing Desmopressin intranasal spray and Indomethacin suppository in people with Renal Colic and Pain, run by Tehran University of Medical Sciences at 2 sites in Iran.
Trial summary
In this study we will compare pain intensity and side effects at different time points after the intranasal administration of desmopressin or placebo in patients with acute renal colic pain. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Renal Colic, Pain
- What is being tested?
- Desmopressin intranasal spray and Indomethacin suppository
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 2 sitesIran
- Study dates
- Mar 2012to Mar 2013
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: 15 to 65 years
- Pain intensity of at least 3
- Clinical diagnosis of renal colic
Who cannot join
- History of hypertension
- History of acute myocardial ischemia
- History of hyponatremia
- Presence of acute rhinitis and flu
- Coagulopathy or anticoagulant therapy
- History of peptic ulcer disease, asthma, renal failure, severe liver failure
Show all 9Show fewer
- Analgesic use over 4 hours ago
- Taking seizure medications (such as carbamazepine)
- Taking any of the following drugs: chlorpropamide, warfarin, clofibrate , epinephrine, Fludrocortisone, heparin, lithium, alcohol
Trial locations and contacts
2 sites in 1 country.
Iran2 sites, 2 recruiting
- Recruiting
Imam Khomeini General Hospital
Tehran, Tehran Province
Mohammad Jalili, MD, 00982166904848, mjalili@tums.ac.ir
Mohammadreza Hedayatshodeh, MD, 00989125357410, mmd.hedy@yahoo.com
- Recruiting
Shariati Hospital
Tehran, Tehran Province
Mohammad Jalili, MD, 00982166904848, mjalili@tums.ac.ir
Mohammadreza Hedayatshodeh, MD
About this study
Official title: Assessment of Analgesic Efficacy of Intranasal Desmopressin in the Treatment of Acute Pain in Patients With Renal Colic
In this study we will compare pain intensity and side effects at different time points after the intranasal administration of desmopressin or placebo in patients with acute renal colic pain.
Read the detailed description
Obstruction of the urinary tract can increase pelvi-ureteric pressure and thus cause renal colic pain, which can be very severe. Conventional therapy consists of non-steroidal anti-inflammatory drugs (NSAIDs) and opioids. NSAIDs have many side effects and opioids are not always available. In addition, the intravenous form of NSAIDs is not routinely available in Iran, and the drug is mainly used in the form of suppository. Due to these reasons, research on newer replacement therapies with fewer side effects is necessary. Desmopressin intranasal spray has already been shown to be partially effective in renal colic pain in a few studies. Due to its lower side effects, we decided to conduct a clinical trial with desmopressin to evaluate pain relief in renal colic. In this study, eighty-eight patients with acute renal colic pain, referring to Imam Khomeini Hospital in Tehran, will be randomly allocated to receive either intranasal desmopressin or placebo. Both groups will also receive 100 milligram indomethacin suppository. Pain intensity will be assessed and recorded using a verbal numeric rating scale, before nasal spray, and in minutes 5, 10, 15, 30, 45 and 60 after receiving the allocated treatment. Possible side effects will also be asked and recorded. The patient and the investigator responsible for recording pain intensity will not be aware of the administered drug. The results will be compared before and after treatment in each group, using appropriate statistical tests.
- Conditions
- Renal Colic, Pain
- Being tested
- Desmopressin intranasal spray, Placebo intranasal spray, Indomethacin suppository
- Keywords
- Renal colic, Pain, Desmopressin, Urinary obstruction, Indomethacin
- Medical subject headings
- Renal Colic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desmopressin intranasal sprayDrug
Also called DDAVP, DesmoMelt, Stimate, Minirin,Desmex
10 microgram per puff, 40 microgram is Descript
Placebo intranasal sprayDrug
Saline spray identical to desmopressin, administered as 4 sprays
Indomethacin suppositoryDrug
Also called Indocin, Indocid, Indochron, INDOMET
Indomethacin suppository 100 milligram single dose
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin intranasal spray | Experimental | Patients in this arm will receive 40 microgram desmopressin intranasal spray \& 100 milligram indomethacin suppository Receives: Drug: Desmopressin intranasal spray; Drug: Indomethacin suppository |
| Placebo intranasal spray | Placebo comparator | Patients in this group will receive placebo nasal spray \& 100 milligram indomethacin suppository Receives: Drug: Placebo intranasal spray; Drug: Indomethacin suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Changes in pain intensity using a verbal numeric rating scale
Measured: baseline till one hour
Secondary outcomes (1)
Side effects
Any perceived side effects reported by the patient, including dry mouth, nausea, and drowsiness.
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
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 Renal ColicStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Jalili, MD, Study chair, Tehran University of Medical SciencesMohammadreza Hedayatshodeh, MD, Study director, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742689
- Sponsor's protocol ID
- 91/130/569
- Status last verified
- Dec 2012
- First submitted
- 3 Dec 2012
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roshani A, Falahatkar S, Khosropanah I, Roshan ZA, Zarkami T, Palizkar M, Emadi SA, Akbarpour M, Khaki N. Assessment of clinical efficacy of intranasal desmopressin spray and diclofenac sodium suppository in treatment of renal colic versus diclofenac sodium alone. Urology. 2010 Mar;75(3):540-2. doi: 10.1016/j.urology.2008.05.053. Epub 2009 Dec 4.
PubMed 19962730Lopes T, Dias JS, Marcelino J, Varela J, Ribeiro S, Dias J. An assessment of the clinical efficacy of intranasal desmopressin spray in the treatment of renal colic. BJU Int. 2001 Mar;87(4):322-5. doi: 10.1046/j.1464-410x.2001.00068.x.
PubMed 11251523
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Analgesic Efficacy of Intranasal Desmopressin in the Treatment of Acute Pain in Patients With Renal Colic
- ClinicalTrials.gov ID
- NCT01742689
- Acronym / sponsor ID
- 91/130/569
- Conditions
- Renal Colic, Pain
- Keywords
- Renal colic, Pain, Desmopressin, Urinary obstruction, Indomethacin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 5 Dec 2012 (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.
In this study we will compare pain intensity and side effects at different time points after the intranasal administration of desmopressin or placebo in patients with acute renal colic pain.
Detailed description
Obstruction of the urinary tract can increase pelvi-ureteric pressure and thus cause renal colic pain, which can be very severe. Conventional therapy consists of non-steroidal anti-inflammatory drugs (NSAIDs) and opioids. NSAIDs have many side effects and opioids are not always available. In addition, the intravenous form of NSAIDs is not routinely available in Iran, and the drug is mainly used in the form of suppository. Due to these reasons, research on newer replacement therapies with fewer side effects is necessary. Desmopressin intranasal spray has already been shown to be partially effective in renal colic pain in a few studies. Due to its lower side effects, we decided to conduct a clinical trial with desmopressin to evaluate pain relief in renal colic. In this study, eighty-eight patients with acute renal colic pain, referring to Imam Khomeini Hospital in Tehran, will be randomly allocated to receive either intranasal desmopressin or placebo. Both groups will also receive 100 milligram indomethacin suppository. Pain intensity will be assessed and recorded using a verbal numeric rating scale, before nasal spray, and in minutes 5, 10, 15, 30, 45 and 60 after receiving the allocated treatment. Possible side effects will also be asked and recorded. The patient and the investigator responsible for recording pain intensity will not be aware of the administered drug. The results will be compared before and after treatment in each group, using appropriate statistical tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desmopressin intranasal spray | Experimental | Drug: Desmopressin intranasal spray, Drug: Indomethacin suppositoryPatients in this arm will receive 40 microgram desmopressin intranasal spray \& 100 milligram indomethacin suppository |
| Placebo intranasal spray | Placebo comparator | Drug: Placebo intranasal spray, Drug: Indomethacin suppositoryPatients in this group will receive placebo nasal spray \& 100 milligram indomethacin suppository |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 15 to 65 years
- Pain intensity of at least 3
- Clinical diagnosis of renal colic
Key exclusion criteria (9 listed)
- History of hypertension
- History of acute myocardial ischemia
- History of hyponatremia
- Presence of acute rhinitis and flu
- Coagulopathy or anticoagulant therapy
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 |
|---|---|---|
| Desmopressin intranasal sprayAlso: DDAVP, DesmoMelt, Stimate, Minirin,Desmex10 microgram per puff, 40 microgram is Descript | Drug | Desmopressin intranasal spray |
| Placebo intranasal spraySaline spray identical to desmopressin, administered as 4 sprays | Drug | Placebo intranasal spray |
| Indomethacin suppositoryAlso: Indocin, Indocid, Indochron, INDOMETIndomethacin suppository 100 milligram single dose | Drug | Desmopressin intranasal spray, Placebo intranasal spray |
Primary outcome
Pain intensity
Time frame: baseline till one hour
Changes in pain intensity using a verbal numeric rating scale
1 secondary outcome
Side effects
Time frame: One hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
- Background: PubMed 19962730Roshani A, Falahatkar S, Khosropanah I, Roshan ZA, Zarkami T, Palizkar M, Emadi SA, Akbarpour M, Khaki N. Assessment of clinical efficacy of intranasal desmopressin spray and diclofenac sodium suppository in treatment of renal colic versus diclofenac sodium alone. Urology. 2010 Mar;75(3):540-2. doi: 10.1016/j.urology.2008.05.053. Epub 2009 Dec 4.
- Background: PubMed 11251523Lopes T, Dias JS, Marcelino J, Varela J, Ribeiro S, Dias J. An assessment of the clinical efficacy of intranasal desmopressin spray in the treatment of renal colic. BJU Int. 2001 Mar;87(4):322-5. doi: 10.1046/j.1464-410x.2001.00068.x.
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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.
Mohammad Jalili, MD study chair
Tehran University of Medical Sciences
Mohammadreza Hedayatshodeh, MD study director
Tehran University of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desmopressin intranasal spray and Indomethacin suppository in people with Renal Colic and Pain, run by Tehran University of Medical Sciences at 2 sites 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 3 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: status not confirmed, as of the sponsor's last update on 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Jalili, MD (+98-21-66904848, mjalili@tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: baseline till one hour). 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 NCT01742689, 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 5 Dec 2012.