Phase 4
N=28
Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics
Gastrointestinal Mucosal Damage
Bottom Line
View on ClinicalTrials.gov: NCT01822665 ↗Enrolled (actual)
28
Serious AEs
1.0%
Results posted
Mar 2014
Primary outcome: Primary: Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule — 0.33; 1.48 Scores on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ibuprofen (Drug); Paracetamol (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule |
0.33; 1.48 | <0.0001 sig |
| SECONDARY GMD Scores of Paracetamol Tablet; Ibuprofen Capsule; Ibuprofen Tablet; and Placebo Tablet |
0.33; 1.48; 1.05; 0.14 | 0.0095 sig |
| SECONDARY Duodenal Mucosal Damage (DMD) Scores |
0.15; 0.26; 0.23; 0.00 | 0.6497 |
| SECONDARY Incidence of Gastric and/or Duodenal Mucosal Injury |
12; 8; 4; 0 | 0.0084 sig |
| SECONDARY Incidence of Fecal Occult Blood |
27; 23; 22; 22; 0; 0 | — |
Summary
This study evaluated the effect of oral fast-dissolving formulations of paracetamol and ibuprofen on the lining of the stomach and duodenum (gastrointestinal mucosa). Endoscopic examinations were conducted to determine the gastrointestinal damage produced post a 7 day treatment regimen.
Eligibility Criteria
Inclusion Criteria
- Body Mass Index: 18-30 kg/m^2
- Body Weight 60-80 kg
- Participant with both a normal stomach and proximal duodenum mucosa as evidenced by endoscopic results
Exclusion Criteria
- Participant with evidence of current/active, or a history of gastrointestinal disease
- Participant with a history of renal disease, pulmonary edema, cardiomyopathy, liver disease, intrinsic coagulation defects, bleeding diseases or anticoagulant therapy
- Participant with a history of using antacids, H2 receptor antagonists, proton pump inhibitors, or misoprostol more than twice a month or has used any of these medications within 1 week of Visit 1.
- Participant with a current or recurrent disease, within 12 months of Visit 1, that could affect the action, absorption, disposition, or excretion of the study treatments or evaluation of the clinical or laboratory tests
Data sourced from ClinicalTrials.gov (NCT01822665). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.