- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02711241
Optimal Analgesia in Acute Gastroenteritis
March 13, 2016 updated by: STALNIKOWICZ-DARVASI RUTH, Hadassah Medical Organization
Optimal Analgesia in Acute Gastroenteritis in Emergency Department Setting: Dipyrone Versus Papaverine
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Jerusalem, Israel
- Hadssah Medical Organisation
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dipyrone
|
1 gram by slow IV infusion
Other Names:
|
Active Comparator: Papaverine
|
80 mg by slow intravenous infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in pain assessment (VAS) as opposed the pain assessment on admission
Time Frame: 30 min, 1 hour, 2 hours, on discharge (up to 24 hours)
|
30 min, 1 hour, 2 hours, on discharge (up to 24 hours)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Need for second analgesic medicine
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ruth Stanikowitz, MD, Hadassah Medical Organization
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
March 1, 2011
First Submitted That Met QC Criteria
March 13, 2016
First Posted (Estimate)
March 17, 2016
Study Record Updates
Last Update Posted (Estimate)
March 17, 2016
Last Update Submitted That Met QC Criteria
March 13, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Peripheral Nervous System Agents
- Urological Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antipyretics
- Phosphodiesterase Inhibitors
- Dipyrone
- Papaverine
Other Study ID Numbers
- AGE123-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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