Postprandial Belching, Postprandial Bloating, Postprandial Eructation
Conditions
Keywords
Pancrelipase, Abdominal bloating, Abdominal pain, Eructation
Brief summary
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.
Interventions
DRUGPancrelipase (Creon) 2 tablets with each meal
Sponsors
Solvay Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal bloating | — |
| Abdominal pain | — |
| Eructation | — |
Countries
United States
Outcome results
None listed