Abdominal CrampsPhase 4HNBNCT02508142
Analgesic Efficacy of Intravenous Hyoscine-N-Butylbromide (HNB) in Abdominal Colic Associated With Acute Gastroenteritis
A Phase 4 study testing Hyoscine-N-Butylbromide in people with Abdominal Cramps, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to assess the analgesic efficacy and safety of intravenous 20 mg Hyoscine-N-Butylbromide versus placebo for the treatment of abdominal colic associated with acute gastroenteritis in the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Cramps
- What is being tested?
- Hyoscine-N-Butylbromide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2015to Aug 2016
- 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
- Adult patients
- Presenting to the emergency department with abdominal cramps associated with acute gastroenteritis
- The pain intensity score upon screening is at least 20 mm on visual analog scale
- Patients who agree to participate and sign the informed consent
Who cannot join
- Patients younger than 18 years
- Pain of > 7 days
- Use of any analgesic within 6 hours of ED presentation
- Concomitant medication with spasmolytics, anticholinergics, drugs affecting gastrointestinal motility such as metoclopramide, loperamide, opioid analgesics
- Patients who were administered dopamine antagonists before screening
- Documented or self-reported hypersensitivity to hyoscine-n-butylbromide
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- Confirmed or suspected pregnancy
- Breastfeeding
- Glaucoma
- Myasthenia gravis
- Benign prostatic hyperplasia or urinary obstruction
- Any suspected other cause of acute abdominal pain
- Peritonism
- Mechanical stenosis of the gastrointestinal tract, paralytic ileus, megacolon
- Previous intestinal resection
- History of inflammatory bowel disease
- Tachyarrhythmia
- Severe dehydration requiring fluid resuscitation immediately
- Unable to consent
- Refused to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli University, Faculty of Medicine, Emergency Departmentt
Kocaeli, 41380
Elif Yaka, M.D., +902623038551, elifpostaciyaka@gmail.com
İbrahim U Özturan, M.D., +902623038577, ozturan.iu@gmail.com
About this study
Official title: Assessment of Analgesic Efficacy and Safety of Intravenous Hyoscine-N-Butylbromide in Patients With Abdominal Colic Associated With Acute Gastroenteritis; a Randomized, Double-blind, Placebo Controlled Study
This study aims to assess the analgesic efficacy and safety of intravenous 20 mg Hyoscine-N-Butylbromide versus placebo for the treatment of abdominal colic associated with acute gastroenteritis in the emergency department.
Read the detailed description
Acute gastroenteritis is a frequent cause of emergency department (ED) presentation. Mainstays of ED treatment are rehydration and antiemetics when needed. Since crampy abdominal pain accompanies (diarrhea) acute gastroenteritis in 67-90% of patients, emergency physicians may have to deal with spasmodic colics in these patients.
Hyoscine-N-butylbromide (HNB), is an anticholinergic agent which has been in use as an antispasmodic agent for sixty years all over the world. It has been studied and revealed various efficacy for several conditions (e.g; biliary colic, renal colic, endoscopic interventions, radiologic interventions, during labor, nonspecific abdominal pain and irritable bowel syndrome).
HNB is commonly used for symptomatic relief of abdominal cramps associated with acute gastroenteritis in the EDs, whereas the literature lacks evidence regarding its efficacy and safety for this condition.
The aim of this study is to assess the analgesic efficacy and safety of intravenous 20 mg hyoscine-n-butylbromide versus placebo in patients with abdominal colic associated with acute gastroenteritis in the emergency department.
- Conditions
- Abdominal Cramps
- Being tested
- Hyoscine-N-Butylbromide
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyoscine-N-ButylbromideDrug
Also called Buscopan, 20mg/2 mL (Boehringer Ingelheim İlaç Ticaret A.Ş)
Study Drug: 20 mg/2 mL Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL) ıntravenous form of Hyoscine-N-Butylbromide in normal saline is in the same appearance with placebo Study drug: 100 mL normal saline (placebo) (totally 100 mL)
Drug: Fentanyl 1 mcg/kg as rescue analgesia at 30th minute
| Study group | Role | What they receive |
|---|---|---|
| Hyoscine-N-Butylbromide | Active comparator | 20 mg Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL) Receives: Drug: Hyoscine-N-Butylbromide |
| Placebo | Placebo comparator | 100 mL normal saline Receives: Drug: Hyoscine-N-Butylbromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the mean pain intensity scores on visual analog scale
Change in the mean pain intensity scores on visual analog scale
Measured: 15, 30, 60 minutes
Secondary outcomes (2)
Adverse events
any adverse reactions
Measured: 6 hours
Incidence of rescue analgesia
Incidence of rescue analgesia (Fentanyl 1mcg/kg) requirement
Measured: at 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal CrampsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Yaka, Kocaeli University
- Investigators
- Elif YAKA, M.D., Principal investigator, Kocaeli University, Faculty of Medicine, Emergency Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508142
- Sponsor's protocol ID
- KocaeliU
- Acronym
- HNB
- Status last verified
- Jul 2015
- First submitted
- 23 Jul 2015
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Analgesic Efficacy and Safety of Intravenous Hyoscine-N-Butylbromide in Patients With Abdominal Colic Associated With Acute Gastroenteritis; a Randomized, Double-blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT02508142
- Acronym / sponsor ID
- HNB / KocaeliU
- Conditions
- Abdominal Cramps
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 24 Jul 2015 (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.
This study aims to assess the analgesic efficacy and safety of intravenous 20 mg Hyoscine-N-Butylbromide versus placebo for the treatment of abdominal colic associated with acute gastroenteritis in the emergency department.
Detailed description
Acute gastroenteritis is a frequent cause of emergency department (ED) presentation. Mainstays of ED treatment are rehydration and antiemetics when needed. Since crampy abdominal pain accompanies (diarrhea) acute gastroenteritis in 67-90% of patients, emergency physicians may have to deal with spasmodic colics in these patients.
Hyoscine-N-butylbromide (HNB), is an anticholinergic agent which has been in use as an antispasmodic agent for sixty years all over the world. It has been studied and revealed various efficacy for several conditions (e.g; biliary colic, renal colic, endoscopic interventions, radiologic interventions, during labor, nonspecific abdominal pain and irritable bowel syndrome).
HNB is commonly used for symptomatic relief of abdominal cramps associated with acute gastroenteritis in the EDs, whereas the literature lacks evidence regarding its efficacy and safety for this condition.
The aim of this study is to assess the analgesic efficacy and safety of intravenous 20 mg hyoscine-n-butylbromide versus placebo in patients with abdominal colic associated with acute gastroenteritis in the emergency department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyoscine-N-Butylbromide | Active comparator | Drug: Hyoscine-N-Butylbromide20 mg Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL) |
| Placebo | Placebo comparator | Drug: Hyoscine-N-Butylbromide100 mL normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients
- Presenting to the emergency department with abdominal cramps associated with acute gastroenteritis
- The pain intensity score upon screening is at least 20 mm on visual analog scale
- Patients who agree to participate and sign the informed consent
Key exclusion criteria (20 listed)
- Patients younger than 18 years
- Pain of > 7 days
- Use of any analgesic within 6 hours of ED presentation
- Concomitant medication with spasmolytics, anticholinergics, drugs affecting gastrointestinal motility such as metoclopramide, loperamide, opioid analgesics
- Patients who were administered dopamine antagonists before screening
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-ButylbromideAlso: Buscopan, 20mg/2 mL (Boehringer Ingelheim İlaç Ticaret A.Ş)Study Drug: 20 mg/2 mL Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL) ıntravenous form of Hyoscine-N-Butylbromide in normal saline is in the same appearance with placebo Study drug: 100 mL normal saline (placebo) (totally 100 mL) Drug: Fentanyl 1 mcg/kg as rescue analgesia at 30th minute | Drug | Hyoscine-N-Butylbromide, Placebo |
Primary outcome
Change in the mean pain intensity scores on visual analog scale
Time frame: 15, 30, 60 minutes
Change in the mean pain intensity scores on visual analog scale
2 secondary outcomes
Adverse events
Time frame: 6 hours
Incidence of rescue analgesia
Time frame: at 30 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
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.
Elif YAKA, M.D. principal investigator
Kocaeli University, Faculty of Medicine, Emergency Department
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 Abdominal Cramps, run by Kocaeli University 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 4 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 30 Jul 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif YAKA, M.D. (+90 262 3038551, elifpostaciyaka@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the mean pain intensity scores on visual analog scale (time frame: 15, 30, 60 minutes). 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 30 Jul 2015.