Acute GastroenteritisPhase 4NCT04682860
Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide
A Phase 4 study testing Hyoscine N Butylbromide in people with Acute Gastroenteritis and Abdominal Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
One of the most common complaints of admission to the emergency room is gastroenteritis. One of the most common complaints in acute gastroenteritis is abdominal pain. The aim of our study is to investigate whether hyoscine butylbromide used within the indication has an effect on abdominal pain due to acute… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Gastroenteritis, Abdominal Pain
- What is being tested?
- Hyoscine N Butylbromide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Sep 2021to 3 Jan 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with watery stools starting in the last 2 weeks and 3 times in 24 hours and abdominal pain
Who cannot join
- Peritonitis
- Hemodynamic instability
- Pregnancy
- Inability to give consent
- Medication given in the emergency room before being included in the study
- Taking pain medication within 4 hours
- Diabetes Mellitus and other neuropathic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide: Randomized Double Blind Placebo Controlled Trial
One of the most common complaints of admission to the emergency room is gastroenteritis. One of the most common complaints in acute gastroenteritis is abdominal pain. The aim of our study is to investigate whether hyoscine butylbromide used within the indication has an effect on abdominal pain due to acute gastroenteritis. The main purpose of our study is to reduce the pain of the patient at 30th and 60th minutes compared to 0th minute.
- Conditions
- Acute Gastroenteritis, Abdominal Pain
- Being tested
- Hyoscine N Butylbromide, Placebo
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyoscine N ButylbromideDrug
Hyoscine N butylbromide injection for the treatment of abdominal pain in acute gastroenteritis
PlaceboOther
2 ml of normal saline injection as placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | In the placebo arm, patients will be slowly injected with 2 ml of normal saline within 30 seconds Receives: Other: Placebo |
| Hyoscine N butylbromide | Active comparator | In the treatment arm, the patient will be injected intravenously with 1ml 20 mg of Hyoscine butylbromide and 1 ml of normal saline intravenously within 30 seconds. Receives: Drug: Hyoscine N Butylbromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Change
Pain change after intervention at 30th and 60th minute. Pain will assesed with Visual Analog Scale (100 mm). 13 mm of change at Visual Analog Scale will assesed as clinically significant.
Measured: 30 minute and1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start8 Sep 2021
- Primary completion3 Dec 2021
- Study completion3 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute GastroenteritisStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagdas Yildirim, Ankara City Hospital Bilkent
- Investigators
- Çağdaş Yıldırım, Ass. Prof, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682860
- Sponsor's protocol ID
- Çağdaş Yıldırım
- Status last verified
- Jan 2022
- First submitted
- 14 Dec 2020
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD maybe shared upon request
Publications
Remington-Hobbs J, Petts G, Harris T. Emergency department management of undifferentiated abdominal pain with hyoscine butylbromide and paracetamol: a randomised control trial. Emerg Med J. 2012 Dec;29(12):989-94. doi: 10.1136/emermed-2011-200474. Epub 2012 Feb 3.
PubMed 22307926Arena C, Amoros JP, Vaillant V, Ambert-Balay K, Chikhi-Brachet R, Jourdan-Da Silva N, Varesi L, Arrighi J, Souty C, Blanchon T, Falchi A, Hanslik T. Acute diarrhea in adults consulting a general practitioner in France during winter: incidence, clinical characteristics, management and risk factors. BMC Infect Dis. 2014 Oct 30;14:574. doi: 10.1186/s12879-014-0574-4.
PubMed 25358721Shane AL, Mody RK, Crump JA, Tarr PI, Steiner TS, Kotloff K, Langley JM, Wanke C, Warren CA, Cheng AC, Cantey J, Pickering LK. 2017 Infectious Diseases Society of America Clinical Practice Guidelines for the Diagnosis and Management of Infectious Diarrhea. Clin Infect Dis. 2017 Nov 29;65(12):1963-1973. doi: 10.1093/cid/cix959.
PubMed 29194529
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide: Randomized Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04682860
- Acronym / sponsor ID
- Çağdaş Yıldırım
- Conditions
- Acute Gastroenteritis, Abdominal Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Jan 2022 (actual)
- First posted
- 24 Dec 2020 (actual)
- 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.
One of the most common complaints of admission to the emergency room is gastroenteritis. One of the most common complaints in acute gastroenteritis is abdominal pain. The aim of our study is to investigate whether hyoscine butylbromide used within the indication has an effect on abdominal pain due to acute gastroenteritis. The main purpose of our study is to reduce the pain of the patient at 30th and 60th minutes compared to 0th minute.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboIn the placebo arm, patients will be slowly injected with 2 ml of normal saline within 30 seconds |
| Hyoscine N butylbromide | Active comparator | Drug: Hyoscine N ButylbromideIn the treatment arm, the patient will be injected intravenously with 1ml 20 mg of Hyoscine butylbromide and 1 ml of normal saline intravenously within 30 seconds. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with watery stools starting in the last 2 weeks and 3 times in 24 hours and abdominal pain
Key exclusion criteria (7 listed)
- Peritonitis
- Hemodynamic instability
- Pregnancy
- Inability to give consent
- Medication given in the emergency room before being included in the study
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 |
|---|---|---|
| Hyoscine N ButylbromideHyoscine N butylbromide injection for the treatment of abdominal pain in acute gastroenteritis | Drug | Hyoscine N butylbromide |
| Placebo2 ml of normal saline injection as placebo | Other | Placebo |
Primary outcome
Pain Change
Time frame: 30 minute and1 hour
Pain change after intervention at 30th and 60th minute. Pain will assesed with Visual Analog Scale (100 mm). 13 mm of change at Visual Analog Scale will assesed as clinically significant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Background: PubMed 22307926Remington-Hobbs J, Petts G, Harris T. Emergency department management of undifferentiated abdominal pain with hyoscine butylbromide and paracetamol: a randomised control trial. Emerg Med J. 2012 Dec;29(12):989-94. doi: 10.1136/emermed-2011-200474. Epub 2012 Feb 3.
- Background: PubMed 25358721Arena C, Amoros JP, Vaillant V, Ambert-Balay K, Chikhi-Brachet R, Jourdan-Da Silva N, Varesi L, Arrighi J, Souty C, Blanchon T, Falchi A, Hanslik T. Acute diarrhea in adults consulting a general practitioner in France during winter: incidence, clinical characteristics, management and risk factors. BMC Infect Dis. 2014 Oct 30;14:574. doi: 10.1186/s12879-014-0574-4.
- Background: PubMed 29194529Shane AL, Mody RK, Crump JA, Tarr PI, Steiner TS, Kotloff K, Langley JM, Wanke C, Warren CA, Cheng AC, Cantey J, Pickering LK. 2017 Infectious Diseases Society of America Clinical Practice Guidelines for the Diagnosis and Management of Infectious Diarrhea. Clin Infect Dis. 2017 Nov 29;65(12):1963-1973. doi: 10.1093/cid/cix959.
- Individual participant dataSharing planned: No. IPD maybe shared upon request
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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.
Çağdaş Yıldırım, Ass. Prof principal investigator
Ankara City Hospital Bilkent
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 Hyoscine N Butylbromide in people with Acute Gastroenteritis and Abdominal Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 4 Jan 2022. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain Change (time frame: 30 minute and1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04682860, which also lists 3 linked publications.
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 4 Jan 2022.