Acute PancreatitisPhase 4NCT02885441
Treatment of Acute Pancreatitis With Ketorolac
A Phase 4 study testing Ketorolac in people with Acute Pancreatitis, run by Ilam University of Medical Sciences at 1 site in Iran.
Trial summary
Patients with acute pancreatitis will be randomly assigned in either study group to receive oral (injection) Ketorolac or the control group. In patients who cannot tolerate oral medications, ketorolac injection will be used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Ketorolac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIran
- Study dates
- Sep 2016to 1 Feb 2019
- Phase
- Phase 4
- 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
- Predicted Severe Acute Pancreatitis
- Enrollment within 72 hours of diagnosis
- Obtaining informed consent
- Age >18 years
Who cannot join
- Heart disease, Hypertension
- Hemorrhagic diathesis, Incomplete hemostasis, High risk of bleeding
- Lactating women
- Pregnancy
- Advanced renal disease
- Hypersensitivity to ketorolac, aspirin, other NSAIDs
Show all 11Show fewer
- Concurrent use with aspirin, other NSAIDs, probenecid, or pentoxifylline
- Active or history of peptic ulcer disease
- Recent or history of GI bleeding or perforation
- Inflammatory bowel disease
- Severe hepatic impairment or active hepatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Patients with acute pancreatitis will be randomly assigned in either study group to receive oral (injection) Ketorolac or the control group. In patients who cannot tolerate oral medications, ketorolac injection will be used.
Read the detailed description
Patients with acute pancreatitis will be randomly assigned in either study group or control group.
- The study group will receive injection or oral Ketorolac.
- The control group will receive standard medical treatment.
Ketorolac is administrated three times daily by mouth or injection starting from the time of admission for the first three days of hospitalization (72 hours).
Hs-CRP will be measured in admission in addition to standard laboratory tests.It will be done every day for up to 5 days, after the administration of study drug or till the time of discharge whichever occurs earlier. Patients will follow up for organ failure involvement and duration of hospitalization. The study will continue to gather clinical follow up information up to four months.
- Conditions
- Acute Pancreatitis
- Being tested
- Ketorolac
- Keywords
- Inflammation
- Medical subject headings
- Pancreatitis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called Toradol
Ketorolac, 10 mg, 3 times daily from time of enrollment until 72 hours from enrollment. For up to a maximum of 9 doses.
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac | Experimental | Ketorolac,10 mg, 3 times daily from time of enrollment until 72 hours from enrollment for up to a maximum of 9 doses, along with the standard medical treatment Receives: Drug: Ketorolac |
| Control | No intervention | The standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in C-Reactive Protein (CRP)
baseline to Day 5
Measured: baseline to Day 5
Secondary outcomes (5)
Number Of Subjects With New Onset Organ Failure During Hospitalization
30 days or until dismissal date whichever occurs earlier
Measured: 30 days or until dismissal date whichever occurs earlier
Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization
30 days or until dismissal date whichever occurs earlier
Measured: 30 days or until dismissal date whichever occurs earlier
Duration of hospitalization
30 days or until dismissal date whichever occurs earlier
Measured: 30 days or until dismissal date whichever occurs earlier
Mortality
30 days or until dismissal date whichever occurs earlier
Measured: 30 days or until dismissal date whichever occurs earlier
Time of beginning and tolerance to nutrition
30 days or until dismissal date whichever occurs earlier
Measured: 30 days or until dismissal date whichever occurs earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilam University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Vahdat Shariatpanahi, Ilam University of Medical Sciences
- Investigators
- Shaahin Shahbazi, MD, Study chair, Head of Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885441
- Sponsor's protocol ID
- 22/52/1663
- Status last verified
- Jan 2019
- First submitted
- 23 Aug 2016
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acute Pancreatitis With Ketorolac
- ClinicalTrials.gov ID
- NCT02885441
- Acronym / sponsor ID
- 22/52/1663
- Conditions
- Acute Pancreatitis
- Keywords
- Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ilam University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 31 Aug 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.
Patients with acute pancreatitis will be randomly assigned in either study group to receive oral (injection) Ketorolac or the control group. In patients who cannot tolerate oral medications, ketorolac injection will be used.
Detailed description
Patients with acute pancreatitis will be randomly assigned in either study group or control group.
- The study group will receive injection or oral Ketorolac.
- The control group will receive standard medical treatment.
Ketorolac is administrated three times daily by mouth or injection starting from the time of admission for the first three days of hospitalization (72 hours).
Hs-CRP will be measured in admission in addition to standard laboratory tests.It will be done every day for up to 5 days, after the administration of study drug or till the time of discharge whichever occurs earlier. Patients will follow up for organ failure involvement and duration of hospitalization. The study will continue to gather clinical follow up information up to four months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac | Experimental | Drug: KetorolacKetorolac,10 mg, 3 times daily from time of enrollment until 72 hours from enrollment for up to a maximum of 9 doses, along with the standard medical treatment |
| Control | No intervention | –The standard medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Predicted Severe Acute Pancreatitis
- Enrollment within 72 hours of diagnosis
- Obtaining informed consent
- Age >18 years
Key exclusion criteria (11 listed)
- Heart disease, Hypertension
- Hemorrhagic diathesis, Incomplete hemostasis, High risk of bleeding
- Lactating women
- Pregnancy
- Advanced renal disease
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 |
|---|---|---|
| KetorolacAlso: ToradolKetorolac, 10 mg, 3 times daily from time of enrollment until 72 hours from enrollment. For up to a maximum of 9 doses. | Drug | Ketorolac |
Primary outcome
Change in C-Reactive Protein (CRP)
Time frame: baseline to Day 5
baseline to Day 5
5 secondary outcomes
Number Of Subjects With New Onset Organ Failure During Hospitalization
Time frame: 30 days or until dismissal date whichever occurs earlier
Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization
Time frame: 30 days or until dismissal date whichever occurs earlier
Duration of hospitalization
Time frame: 30 days or until dismissal date whichever occurs earlier
Mortality
Time frame: 30 days or until dismissal date whichever occurs earlier
Time of beginning and tolerance to nutrition
Time frame: 30 days or until dismissal date whichever occurs earlier
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Individual participant dataSharing planned: No
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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.
Shaahin Shahbazi, MD study chair
Head of Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac in people with Acute Pancreatitis, run by Ilam University of Medical Sciences at 1 site in Iran.
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 4 inclusion and 11 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 15 May 2019. 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 Iran. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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. 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 C-Reactive Protein (CRP) (time frame: baseline to Day 5). 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 15 May 2019.