NCT03865004

Brief Summary

This randomized, placebo-controlled trial evaluated the analgesic efficacy and safety of intravenous morphine-paracetamol combination and morphine-dexketoprofen combination morphine for the optimum treatment of renal colic. Combination of IV morphine and paracetamol is as effective and rapid as combination of IV Morphine and IV dexketoprophen for optimum treating of renal colic.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2015

Typical duration for phase_4

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

March 4, 2019

Last Update Submit

March 5, 2019

Conditions

Renal Colic

Outcome Measures

Primary Outcomes (1)

  • pain reductions in VAS scores during the 60th and 90th minutes

    60 minutes

Secondary Outcomes (1)

  • Need for rescue analgesic

    30 minutes

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Drug: Paracetamol+MorphineDrug: Dexketoprofen plus MorphineDrug: Placebo plus Morphine

Paracetamol

ACTIVE COMPARATOR
Drug: Paracetamol+MorphineDrug: Dexketoprofen plus MorphineDrug: Placebo plus Morphine

Dexketoprofene

ACTIVE COMPARATOR
Drug: Paracetamol+MorphineDrug: Dexketoprofen plus MorphineDrug: Placebo plus Morphine

Interventions

Paracetamol+MorphineDRUG

1gr paracetamol plus 0.1 mg/kg morphine were performed simultanously

Also known as: Parol
DexketoprofeneParacetamolPlacebo
Dexketoprofen plus MorphineDRUG

Intravenous 75 mg Dexketoprofen plus 0,1 mg/kg morphine were performed simultanously

Also known as: Arveles
DexketoprofeneParacetamolPlacebo
Placebo plus MorphineDRUG

100 cc NaCl plus 0.1 mg/kg morphine were performed simultanously

Also known as: SF
DexketoprofeneParacetamolPlacebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Colic

Interventions

dexketoprofen trometamolMorphine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 6, 2019

Study Start

October 17, 2015

Primary Completion

October 17, 2016

Study Completion

October 17, 2018

Last Updated

March 6, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share