Analgesic Efficacy of Intranasal Desmopressin in Acute Re... | NCT01742689

Studies
Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic

NCT01742689

Sponsor

Tehran University of Medical Sciences

Status

Unknown status

Last Update Posted

Dec 5, 2012Estimated

Enrollment

88Estimated

Phase

Phase 3

Conditions

Renal Colic
Pain

Interventions

Desmopressin intranasal spray
Placebo intranasal spray
Indomethacin suppository

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Mar 2013Estimated

Completion Date

Mar 2013Estimated

First Submitted Date

Dec 3, 2012

First Submission Date that Met QC Criteria

Dec 4, 2012

First Posted Date

Dec 5, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2012

Last Update Posted Date

Dec 5, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Desmopressin intranasal spray	Experimental	Patients in this arm will receive 40 microgram desmopressin intranasal spray & 100 milligram indomethacin suppository	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	Drug: Placebo intranasal spray Drug: Indomethacin suppository

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Desmopressin intranasal spray	Drug	10 microgram per puff, 40 microgram is Descript	Desmopressin intranasal spray

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain intensity	Changes in pain intensity using a verbal numeric rating scale	baseline till one hour

Secondary Outcomes

Measure	Description	Time Frame
Side effects	Any perceived side effects reported by the patient, including dry mouth, nausea, and drowsiness.	One hour

Other Outcomes

Measure	Description	Time Frame
Use of opioid as a rescue drug	Whether or not the patient care team had to administer opioids due to uncontrolled pain	One hour

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohammad Jalili, MD	Contact	+98-21-66904848		mjalili@tums.ac.ir

Overall Officials

Name	Affiliation	Role
Mohammad Jalili, MD	Tehran University of Medical Sciences	Study Chair
Mohammadreza Hedayatshodeh, MD	Tehran University of Medical Sciences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Imam Khomeini General Hospital	Recruiting	Tehran	Tehran Province		Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19962730	Background	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.
11251523

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D003894	Deamino Arginine Vasopressin
D007213	Indomethacin

ID	Term
D001127	Arginine Vasopressin
D014667	Vasopressins
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones

ID	Term
D056844	Renal Colic
D010146	Pain