DyspepsiaPhase 4NCT01281501
Symptomatic Relief of Acute Dyspeptic Pain in Emergency Department With Pantoprazole
A Phase 4 study testing Normal saline, Pantoprazole and Oral antacid in people with Dyspepsia and Emergency, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate the immediate synergistic effect on the relief of severe acid-related dyspeptic pain by adding intravenous pantoprazole to the combination of oral antacid and antispasmodic agent (the conventional treatment). Read more about this study
- Who is it for?
- Ages 15 to 50 years
- What is being tested?
- Normal saline, Pantoprazole and Oral antacid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2011to Oct 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- clinical diagnosis of acid-related dyspepsia
- age 15 to 50 years
Who cannot join
- pre-treatment 100-millimeter linear Visual Analog Scale (100-mm VAS) pain scores less than 5.0
- known cases of malignancies or terminal illnesses
- known cases of major medical problems
- allergic to studied drugs
- contraindicated to hyoscine butylbromide (glaucoma, myasthenia gravis, paralytic ileus, pyloric stenosis, prostatic enlargement, porphyria)
- received acid antisecretory agents (proton pump inhibitors or histamine-2 receptor antagonists), antispasmodic agents, alcoholic consumption, nonsteroidal anti-inflammatory drugs, aspirin and steroids within 5 days or oral antacids within 4 hours prior to the visit
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- receiving clopidogrel, statins, iron therapies, warfarins, antiretroviral agents, which may have serious drug interaction with the proton pump inhibitors
- receiving drugs that have strong anticholinergic activities (e.g. acetylcholinesterase inhibitors for Parkinson's or Alzheimer diseases, antihistamines, antispasmodic agents, antipsychotics, skeletal muscle relaxants, tricyclic antidepressants) or decongestants, which may have serious drug interaction with hyoscine butylbromide
- suspected other alternative diagnoses (e.g. gut obstruction, biliary colic, pancreatitis, hepatitis or localized hepatobiliary infections, etc.)
- pregnancy or breast-feeding participants
- did not comprehend the Visual Analog Scale (VAS) evaluation
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Emergency Medicine Unit, King Chulalongkorn Memorial Hospital
Patumwan, Bangkok, 11130
About this study
Official title: A Randomized, Controlled Trial of Adding Intravenous Pantoprazole to Conventional Treatment for the Immediate Relief of Dyspeptic Pain
The purpose of this study is to evaluate the immediate synergistic effect on the relief of severe acid-related dyspeptic pain by adding intravenous pantoprazole to the combination of oral antacid and antispasmodic agent (the conventional treatment).
Read the detailed description
Acid-related dyspepsia is common among the population. Number of these patients may have so severe symptoms that can lead them to the emergency department. Mixtures of antacid and antispasmodic were widely used over decades to relieve this acute pain with moderate, yet questionable, improvement in pain score. Proton pump inhibitors (PPIs), the novel acid-lowering agents, are undoubtedly effective to reduce acid secretion and control dyspeptic symptoms in short-term and long-term duration. To our knowledge, no previous study was conducted to evaluate the efficacy of such agents on immediate pain relief in patients with severe dyspeptic symptoms in emergency care. Clinically, they are frequently used to treat this circumstance in an unofficial manner since intravenous proton pump inhibitor alone is not yet considered as a well-approved indication to alleviate such condition. Pantoprazole, a proton pump inhibitor, reaches its peak serum concentration within one hour and its acid-lowering effect occurred within first hour following a single intravenous infusion. Thus, it theoretically has rapid onset and prolonged action on acid reduction. Our primary aim of the study is to evaluate the immediate effect of intravenous pantoprazole in addition to the combination of oral antacid and antispasmodic agent (the conventional regimen) on the relief of severe acid-related dyspeptic pain.
- Being tested
- Normal saline, Pantoprazole, Oral antacid, Hyoscine butylbromide
- Keywords
- Dyspepsia, Emergency treatment, Pantoprazole, Antacid, Pain measurement
- Medical subject headings
- Dyspepsia, Emergencies, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
10 ml of 0.9% sodium chloride solution
PantoprazoleDrug
Also called Controloc (Protonix)
80 mg of intravenous pantoprazole
Oral antacidDrug
Also called Antacid
30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide)
Hyoscine butylbromideDrug
Also called Buscopan
20 mg of intravenous hyoscine butylbromide
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline Receives: Drug: Normal saline; Drug: Oral antacid; Drug: Hyoscine butylbromide |
| Pantoprazole | Experimental | Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole Receives: Drug: Pantoprazole; Drug: Oral antacid; Drug: Hyoscine butylbromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment
Post-treatment VAS will be consecutively measured every 15 minutes until 1 hour after treatment. Minimal and maximal VAS score of every measurement is 0 to 100 millimeters. VAS scores at 1 hour after treatment were the primary outcome measurement. The patients who had <50% decrement between pre- and 1-hour post-treatment VAS or post-treatment scores > 40 millimeters were defined as "Non-responders"(worse outcome). In the same way, those who had ≥ 50% decrement between pre- and 1-hour post-treatment VAS and post-treatment scores≤ 40 millimeters were defined as "Responders" (good outcome).
Measured: 1 hour after treatment
Secondary outcomes (4)
Number of Participants in the Predefined "Responders"
"Responders" define the participants who have ≥ 50% decrease in post-treatment pain scores compared with the pre-treatment evaluation and also have the post-treatment scores ≤ 40 at the end of the study.
Measured: pretreatment and 1 hour after treatment
Number of Participants in the Predefined "Non-responders"
"Non-responders" defined the participants who had < 50% decrease in post-treatment VAS compared with pre-treatment evaluation or post-treatment scores > 40 at the end of the study.
Measured: pretreatment and 1 hour after treatment
Number of Participants With Adverse Effect
The adverse effects include blurred vision, dry mouth, dizziness, headache, palpitation and diarrhea.
Measured: 1 hour after treatment
Number of Participants That Have Overall Satisfaction on the Treatment
The satisfaction will be assessed by a simple, self-reported yes/no question.
Measured: 1 hour after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khrongwong Musikatavorn, MD., Chulalongkorn University
- Investigators
- Khrongwong Musikatavorn, MD, Principal investigator, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281501
- Sponsor's protocol ID
- 619/2010
- Status last verified
- Sep 2013
- First submitted
- 17 Jan 2011
- Last updated
- 18 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Musikatavorn K, Tansangngam P, Lumlertgul S, Komindr A. A randomized controlled trial of adding intravenous pantoprazole to conventional treatment for the immediate relief of dyspeptic pain. Am J Emerg Med. 2012 Nov;30(9):1737-42. doi: 10.1016/j.ajem.2012.02.001. Epub 2012 Mar 29.
PubMed 22463973
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Adding Intravenous Pantoprazole to Conventional Treatment for the Immediate Relief of Dyspeptic Pain
- ClinicalTrials.gov ID
- NCT01281501
- Acronym / sponsor ID
- 619/2010
- Keywords
- Dyspepsia, Emergency treatment, Pantoprazole, Antacid, Pain measurement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 24 Jan 2011 (estimated)
- Results
- Posted 27 Jul 2012
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 evaluate the immediate synergistic effect on the relief of severe acid-related dyspeptic pain by adding intravenous pantoprazole to the combination of oral antacid and antispasmodic agent (the conventional treatment).
Detailed description
Acid-related dyspepsia is common among the population. Number of these patients may have so severe symptoms that can lead them to the emergency department. Mixtures of antacid and antispasmodic were widely used over decades to relieve this acute pain with moderate, yet questionable, improvement in pain score. Proton pump inhibitors (PPIs), the novel acid-lowering agents, are undoubtedly effective to reduce acid secretion and control dyspeptic symptoms in short-term and long-term duration. To our knowledge, no previous study was conducted to evaluate the efficacy of such agents on immediate pain relief in patients with severe dyspeptic symptoms in emergency care. Clinically, they are frequently used to treat this circumstance in an unofficial manner since intravenous proton pump inhibitor alone is not yet considered as a well-approved indication to alleviate such condition. Pantoprazole, a proton pump inhibitor, reaches its peak serum concentration within one hour and its acid-lowering effect occurred within first hour following a single intravenous infusion. Thus, it theoretically has rapid onset and prolonged action on acid reduction. Our primary aim of the study is to evaluate the immediate effect of intravenous pantoprazole in addition to the combination of oral antacid and antispasmodic agent (the conventional regimen) on the relief of severe acid-related dyspeptic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Drug: Normal saline, Drug: Oral antacid, Drug: Hyoscine butylbromideOral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline |
| Pantoprazole | Experimental | Drug: Pantoprazole, Drug: Oral antacid, Drug: Hyoscine butylbromideOral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- clinical diagnosis of acid-related dyspepsia
- age 15 to 50 years
Key exclusion criteria (11 listed)
- pre-treatment 100-millimeter linear Visual Analog Scale (100-mm VAS) pain scores less than 5.0
- known cases of malignancies or terminal illnesses
- known cases of major medical problems
- allergic to studied drugs
- contraindicated to hyoscine butylbromide (glaucoma, myasthenia gravis, paralytic ileus, pyloric stenosis, prostatic enlargement, porphyria)
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 |
|---|---|---|
| Normal saline10 ml of 0.9% sodium chloride solution | Drug | Conventional |
| PantoprazoleAlso: Controloc (Protonix)80 mg of intravenous pantoprazole | Drug | Pantoprazole |
| Oral antacidAlso: Antacid30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide) | Drug | Conventional, Pantoprazole |
| Hyoscine butylbromideAlso: Buscopan20 mg of intravenous hyoscine butylbromide | Drug | Conventional, Pantoprazole |
Primary outcome
Pain Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment
Time frame: 1 hour after treatment
Post-treatment VAS will be consecutively measured every 15 minutes until 1 hour after treatment. Minimal and maximal VAS score of every measurement is 0 to 100 millimeters. VAS scores at 1 hour after treatment were the primary outcome measurement. The patients who had <50% decrement between pre- and 1-hour post-treatment VAS or post-treatment scores > 40 millimeters were defined as "Non-responders"(worse outcome). In the same way, those who had ≥ 50% decrement between pre- and 1-hour post-treatment VAS and post-treatment scores≤ 40 millimeters were defined as "Responders" (good outcome).
4 secondary outcomes
Number of Participants in the Predefined "Responders"
Time frame: pretreatment and 1 hour after treatment
Number of Participants in the Predefined "Non-responders"
Time frame: pretreatment and 1 hour after treatment
Number of Participants With Adverse Effect
Time frame: 1 hour after treatment
Number of Participants That Have Overall Satisfaction on the Treatment
Time frame: 1 hour after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22463973Musikatavorn K, Tansangngam P, Lumlertgul S, Komindr A. A randomized controlled trial of adding intravenous pantoprazole to conventional treatment for the immediate relief of dyspeptic pain. Am J Emerg Med. 2012 Nov;30(9):1737-42. doi: 10.1016/j.ajem.2012.02.001. Epub 2012 Mar 29.
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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.
Khrongwong Musikatavorn, MD principal investigator
Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital
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 Normal saline, Pantoprazole and Oral antacid in people with Dyspepsia and Emergency, run by Chulalongkorn University at 1 site in Thailand.
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 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: finished, as of the sponsor's last update on 18 Sep 2013. 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 Thailand. 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?
Yes. Results are posted in the registry (first posted 27 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Scores on the 100-millimeter Visual Analog Scale (VAS) at 1 Hour After Treatment (time frame: 1 hour after treatment). 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 NCT01281501, which also lists 1 linked publication.
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 18 Sep 2013.