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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01742689
Other study ID # 91/130/569
Secondary ID
Status Recruiting
Phase Phase 3
First received December 3, 2012
Last updated December 4, 2012
Start date March 2012
Est. completion date March 2013

Study information

Verified date December 2012
Source Tehran University of Medical Sciences
Contact Mohammad Jalili, MD
Phone +98-21-66904848
Email mjalili@tums.ac.ir
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 88
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 65 Years
Eligibility Inclusion Criteria:

- Age: 15 to 65 years

- Pain intensity of at least 3

- Clinical diagnosis of renal colic

Exclusion Criteria:

- 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

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Desmopressin intranasal spray
10 microgram per puff, 40 microgram is Descript
Placebo intranasal spray
Saline spray identical to desmopressin, administered as 4 sprays
Indomethacin suppository
Indomethacin suppository 100 milligram single dose

Locations

Country Name City State
Iran, Islamic Republic of Imam Khomeini General Hospital Tehran
Iran, Islamic Republic of Shariati Hospital Tehran

Sponsors (1)

Lead Sponsor Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (2)

Lopes 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Use of opioid as a rescue drug Whether or not the patient care team had to administer opioids due to uncontrolled pain One hour No
Primary Pain intensity Changes in pain intensity using a verbal numeric rating scale baseline till one hour No
Secondary Side effects Any perceived side effects reported by the patient, including dry mouth, nausea, and drowsiness. One hour Yes
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