Last updated: 11/04/2018 04:18:08
Gastrointestinal safety evaluation of two over the counter analgesics
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Study to Investigate the Gastrointestinal Safety of OTC Analgesics in Healthy Volunteers by Endoscopic Examination
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Gastromucosal damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule
Timeframe: Day 7
Secondary outcomes:
GMD Scores of Paracetamol Tablet; Ibuprofen Capsule; Ibuprofen Tablet; and Placebo Tablet
Timeframe: Day 7
Duodenal mucosal damage (DMD) scores
Timeframe: Day 7
Incidence of gastric and/or duodenal mucosal injury
Timeframe: Day 7
Incidence of fecal occult blood
Timeframe: Day 7
Interventions:
Enrollment:
28
Primary completion date:
2012-31-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Gastrointestinal Mucosal Damage
Product
ibuprofen, paracetamol
Collaborators
Not applicable
Study date(s)
February 2012 to July 2012
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
Yes
- Body Mass Index: 18-30 kg/m^2
- Body Weight 60-80 kg
- 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
Inclusion and exclusion 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
Trial location(s)
Location
Houston Institute for Clinical Research
Houston, TX, United States, 77074
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2012-31-07
Actual study completion date
2012-31-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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