Optimal Analgesia in Acute Gastroenteritis | NCT02711241

Studies
Optimal Analgesia in Acute Gastroenteritis

NCT02711241

Sponsor

Hadassah Medical Organization

Status

Terminated

Last Update Posted

Mar 17, 2016Estimated

Enrollment

15Actual

Phase

Phase 3

Conditions

Gastroenteritis

Interventions

Dipyrone
Papaverine

Countries

Israel

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

Mar 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not enough patients

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Mar 1, 2011

First Submission Date that Met QC Criteria

Mar 13, 2016

First Posted Date

Mar 17, 2016Estimated

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

Mar 13, 2016

Last Update Posted Date

Mar 17, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

STALNIKOWICZ-DARVASI RUTH, Professsor, Hadassah Medical OrganizationPrincipal Investigator

Lead Sponsor

Hadassah Medical OrganizationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

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

Detailed Description

Not provided

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

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dipyrone	Active Comparator		Drug: Dipyrone
Papaverine	Active Comparator		Drug: Papaverine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dipyrone	Drug	1 gram by slow IV infusion	Dipyrone	Optalgin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Need for second analgesic medicine		24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

acute gastroenteritis
VAS scale of pain perception at least 4

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ruth Stanikowitz, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadssah Medical Organisation		Jerusalem			Israel

Condition Browse Module

MeSH Terms

ID	Term
D005759	Gastroenteritis
D000377	Agnosia
D004630	Emergencies

Ancestor Terms

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004177	Dipyrone
D010208	Papaverine

Ancestor Terms

ID	Term
D000632	Aminopyrine
D047069	Pyrazolones
D011720	Pyrazoles
D001393	Azoles
D006573

Browse Leaves

Not provided

Browse Branches

Not provided