NCT02711241

Brief Summary

The purpose of this study is to find out an optimal way of analgesia in case of acute infectious gastroenteritis the investigators are going to compare two medicines that are used on everyday basis (without being ever before subject to scientifical study): Dipyrone and papaverine The study is done in the Emergency Department setting. Thus, only first 6 hours of treatment is included in study

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2011

Completed
5 years until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

March 1, 2011

Last Update Submit

March 13, 2016

Conditions

Gastroenteritis

Keywords

GastroenteritisAnalgesiaEmergency department

Outcome Measures

Primary Outcomes (1)

  • Change in pain assessment (VAS) as opposed the pain assessment on admission

    30 min, 1 hour, 2 hours, on discharge (up to 24 hours)

Secondary Outcomes (1)

  • Need for second analgesic medicine

    24 hours

Study Arms (2)

Dipyrone

ACTIVE COMPARATOR
Drug: Dipyrone

Papaverine

ACTIVE COMPARATOR
Drug: Papaverine

Interventions

DipyroneDRUG

1 gram by slow IV infusion

Also known as: Optalgin
Dipyrone
PapaverineDRUG

80 mg by slow intravenous infusion

Papaverine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute gastroenteritis
  • VAS scale of pain perception at least 4

You may not qualify if:

  • pregnancy
  • allergy to any one of study preparations
  • blood pressure less than 85 on admission
  • surgical condition (acute abdomen) suspected or diagnosed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadssah Medical Organisation

Jerusalem, Israel

Location

MeSH Terms

Conditions

GastroenteritisAgnosiaEmergencies

Interventions

DipyronePapaverine

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

AminopyrinePyrazolonesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzylisoquinolinesAlkaloidsOpiate AlkaloidsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ruth Stanikowitz, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professsor

Study Record Dates

First Submitted

March 1, 2011

First Posted

March 17, 2016

Study Start

June 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

March 17, 2016

Record last verified: 2016-03

Locations

IL(1)