GastroenteritisPhase 3NCT02711241
Optimal Analgesia in Acute Gastroenteritis
A Phase 3 study testing Dipyrone and Papaverine in people with Gastroenteritis, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroenteritis
- What is being tested?
- Dipyrone and Papaverine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to Dec 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute gastroenteritis
- VAS scale of pain perception at least 4
Who cannot join
- pregnancy
- allergy to any one of study preparations
- blood pressure less than 85 on admission
- surgical condition (acute abdomen) suspected or diagnosed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Gastroenteritis
- Being tested
- Dipyrone, Papaverine
- Keywords
- Gastroenteritis, Analgesia, Emergency department
- Medical subject headings
- Gastroenteritis, Agnosia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DipyroneDrug
Also called Optalgin
1 gram by slow IV infusion
PapaverineDrug
80 mg by slow intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Dipyrone | Active comparator | Not described Receives: Drug: Dipyrone |
| Papaverine | Active comparator | Not described Receives: Drug: Papaverine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain assessment (VAS) as opposed the pain assessment on admission
Measured: 30 min, 1 hour, 2 hours, on discharge (up to 24 hours)
Secondary outcomes (1)
Need for second analgesic medicine
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Not enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, STALNIKOWICZ-DARVASI RUTH, Hadassah Medical Organization
- Investigators
- Ruth Stanikowitz, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711241
- Sponsor's protocol ID
- AGE123-HMO-CTIL
- Status last verified
- Mar 2016
- First submitted
- 1 Mar 2011
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Analgesia in Acute Gastroenteritis in Emergency Department Setting: Dipyrone Versus Papaverine
- ClinicalTrials.gov ID
- NCT02711241
- Acronym / sponsor ID
- AGE123-HMO-CTIL
- Conditions
- Gastroenteritis
- Keywords
- Gastroenteritis, Analgesia, Emergency department
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patients
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dipyrone | Active comparator | Drug: Dipyrone |
| Papaverine | Active comparator | Drug: Papaverine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acute gastroenteritis
- VAS scale of pain perception at least 4
Key exclusion criteria (4 listed)
- pregnancy
- allergy to any one of study preparations
- blood pressure less than 85 on admission
- surgical condition (acute abdomen) suspected or diagnosed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DipyroneAlso: Optalgin1 gram by slow IV infusion | Drug | Dipyrone |
| Papaverine80 mg by slow intravenous infusion | Drug | Papaverine |
Primary outcome
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)
1 secondary outcome
Need for second analgesic medicine
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Not enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Stanikowitz, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dipyrone and Papaverine in people with Gastroenteritis, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Not enough patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.