NCT01742689

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

December 3, 2012

Last Update Submit

December 4, 2012

Conditions

Renal ColicPain

Keywords

Renal colicPainDesmopressinUrinary obstructionIndomethacin

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Changes in pain intensity using a verbal numeric rating scale

    baseline till one hour

Secondary Outcomes (1)

  • Side effects

    One hour

Other Outcomes (1)

  • Use of opioid as a rescue drug

    One hour

Study Arms (2)

Desmopressin intranasal spray

EXPERIMENTAL

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

Drug: Desmopressin intranasal sprayDrug: Indomethacin suppository

Placebo intranasal spray

PLACEBO COMPARATOR

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

Drug: Placebo intranasal sprayDrug: Indomethacin suppository

Interventions

Desmopressin intranasal sprayDRUG

10 microgram per puff, 40 microgram is Descript

Also known as: DDAVP, DesmoMelt, Stimate, Minirin,Desmex
Desmopressin intranasal spray
Placebo intranasal sprayDRUG

Saline spray identical to desmopressin, administered as 4 sprays

Placebo intranasal spray
Indomethacin suppositoryDRUG

Indomethacin suppository 100 milligram single dose

Also known as: Indocin, Indocid, Indochron, INDOMET
Desmopressin intranasal sprayPlacebo intranasal spray

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 15 to 65 years
  • Pain intensity of at least 3
  • Clinical diagnosis of renal colic

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Imam Khomeini General Hospital

Tehran, Tehran Province, Iran

RECRUITING

Shariati Hospital

Tehran, Tehran Province, Iran

RECRUITING

Related Publications (2)

  • 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.

    PMID: 19962730BACKGROUND

  • 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. doi: 10.1046/j.1464-410x.2001.00068.x.

    PMID: 11251523BACKGROUND

MeSH Terms

Conditions

Renal ColicPain

Interventions

Deamino Arginine VasopressinIndomethacin

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arginine VasopressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mohammad Jalili, MD

    Tehran University of Medical Sciences

    STUDY CHAIR

  • Mohammadreza Hedayatshodeh, MD

    Tehran University of Medical Sciences

    STUDY DIRECTOR

Central Study Contacts

Mohammad Jalili, MD

CONTACT

+98-21-66904848mjalili@tums.ac.ir

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2012

First Posted

December 5, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

IR(2)