Postprandial BloatingPhase 3NCT00266721
Efficacy of Pancrelipase on Postprandial Belching and Bloating.
A Phase 3 study testing Pancrelipase (Creon) 2 tablets with each meal in people with Postprandial Bloating and Postprandial Belching, run by Solvay Pharmaceuticals at 1 site in United States.
Trial summary
The hypothesis of this study is that the administration of pancrelipase with meals will benefit symptoms of post-prandial bloating, pain and eructation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postprandial Bloating, Postprandial Belching, Postprandial Eructation
- What is being tested?
- Pancrelipase (Creon) 2 tablets with each meal
- Type of treatment
- Pill or oral medicine
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Oct 2000
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will have either bothersome upper abdominal discomfort, bloating (feeling of abdominal distention) or belching following meals for at least 12 month's duration. Subjects must have had a normal upper gastrointestinal endoscopy and/or upper GI series during the preceding three years.
Who cannot join
- Individuals with a history suggestive of organic disease such as recent weight loss, nausea, vomiting, GERD, recent changes in bowel habits will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
The hypothesis of this study is that the administration of pancrelipase with meals will benefit symptoms of post-prandial bloating, pain and eructation.
Read the detailed description
Subjects will complete a double-blind crossover study in which, for one week periods, they will receive two pancrelipase tablets with each of the three major meals or a similarly administered identical placebo. Three times daily, subjects will rate the severity of belching, epigastric discomfort, epigastric fullness, bloating, and nausea.
- Being tested
- Pancrelipase (Creon) 2 tablets with each meal
- Keywords
- Pancrelipase, Abdominal bloating, Abdominal pain, Eructation
- Medical subject headings
- Abdominal Pain, Eructation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancrelipase (Creon) 2 tablets with each mealDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal bloating
Abdominal pain
Eructation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2005 (estimated)
- Study startJan 2000
- Study completionOct 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial BloatingStudies 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
- Crossover
- Masking
- Double blind
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael D Levitt, MD, Principal investigator, Minneapolis VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266721
- Sponsor's protocol ID
- 2355
- Status last verified
- Dec 2000
- First submitted
- 15 Dec 2005
- Last updated
- 19 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pancrelipase on Postprandial Belching and Bloating.
- ClinicalTrials.gov ID
- NCT00266721
- Acronym / sponsor ID
- 2355
- Keywords
- Pancrelipase, Abdominal bloating, Abdominal pain, Eructation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2000
- Study completion
- Oct 2000
- First posted
- 19 Dec 2005 (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 hypothesis of this study is that the administration of pancrelipase with meals will benefit symptoms of post-prandial bloating, pain and eructation.
Detailed description
Subjects will complete a double-blind crossover study in which, for one week periods, they will receive two pancrelipase tablets with each of the three major meals or a similarly administered identical placebo. Three times daily, subjects will rate the severity of belching, epigastric discomfort, epigastric fullness, bloating, and nausea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects will have either bothersome upper abdominal discomfort, bloating (feeling of abdominal distention) or belching following meals for at least 12 month's duration. Subjects must have had a normal upper gastrointestinal endoscopy and/or upper GI series during the preceding three years.
Key exclusion criteria (1 listed)
- Individuals with a history suggestive of organic disease such as recent weight loss, nausea, vomiting, GERD, recent changes in bowel habits will be excluded from 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 |
|---|---|---|
| Pancrelipase (Creon) 2 tablets with each meal | Drug | – |
Primary outcome
Abdominal bloating
Abdominal pain
Eructation
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 19 Dec 2005.
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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.
Michael D Levitt, MD principal investigator
Minneapolis VAMC
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 Pancrelipase (Creon) 2 tablets with each meal in people with Postprandial Bloating and Postprandial Belching, run by Solvay Pharmaceuticals at 1 site in United States.
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 1 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 19 Dec 2005. 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 United States. 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 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?
Abdominal bloating. The study lists 3 primary outcomes in all. 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 19 Dec 2005.