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Trial · Interventional

Status unknownPhase 3Registry data

Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic

Overview

Status
Status unknown
Phase
Phase 3
Enrollment
88 participants (estimated)
Sponsor
Tehran University of Medical Sciences · Other
Design
Randomized · Quadruple masking
Countries
1 country

Iran

Start
Mar 2012
Primary completion
Mar 2013 (estimated)
Completion
Mar 2013 (estimated)
First posted
5 Dec 2012 (estimated)
Last update posted
5 Dec 2012 (estimated)
Conditions
Renal Colic · Pain

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph 3

    Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic

    NCT01742689

    Mar 2012 to est. Mar 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Desmopressin intranasal sprayDrug
  • Placebo intranasal sprayDrug
  • Indomethacin suppositoryDrug

Arms2

  • Experimental

    Desmopressin intranasal spray

    Patients in this arm will receive 40 microgram desmopressin intranasal spray \& 100 milligram indomethacin suppository

  • Placebo comparator

    Placebo intranasal spray

    Patients in this group will receive placebo nasal spray \& 100 milligram indomethacin suppository

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Pain intensity

    Time frame · baseline till one hour

    Registry description

    Changes in pain intensity using a verbal numeric rating scale

Secondary outcomes(1)
  1. Side effects

    Time frame · One hour

    Registry description

    Any perceived side effects reported by the patient, including dry mouth, nausea, and drowsiness.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2001

7 results

An assessment of the clinical efficacy of intranasal desmopressin spray in the treatment of renal colic.

Lopes et al. 2001BJU internationalcited by 39

PMID 11251523DOI 10.1046/j.1464-410x.2001.00068.xPUB-11251523

Full text at the publisher7 results

More studies

1 study on this page

Indexing hint: Clinical trial · 2010

Assessment of clinical efficacy of intranasal desmopressin spray and diclofenac sodium suppository in treatment of renal colic versus diclofenac sodium alone.

Roshani et al. 2010Urologycited by 15

PMID 19962730DOI 10.1016/j.urology.2008.05.053PUB-19962730

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 15 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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