Gastrointestinal Mucosal DamagePhase 4NCT01822665
Gastrointestinal Safety Evaluation of Two Over the Counter Analgesics
A Phase 4 study testing Ibuprofen and Paracetamol in people with Gastrointestinal Mucosal Damage, run by GlaxoSmithKline at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Mucosal Damage
- What is being tested?
- Ibuprofen and Paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jul 2012
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Houston Institute for Clinical Research
Houston, Texas, 77074
About this study
Official title: A Study to Investigate the Gastrointestinal Safety of OTC Analgesics in Healthy Volunteers by Endoscopic Examination
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.
- Conditions
- Gastrointestinal Mucosal Damage
- Being tested
- Ibuprofen, Paracetamol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Liquid gelation capsules or tablets of 400 mg strength
ParacetamolDrug
Paracetamol fast dissolving tablets of 500 mg strength
PlaceboOther
Placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol Tablet | Active comparator | Paracetamol 500 mg tablet, 2 tablets administered 4 times a day (QID) with water. Receives: Drug: Paracetamol |
| Ibuprofen Tablet | Active comparator | Ibuprofen 400 mg tablet, 2 tablets administered three times a day (TID) with water Receives: Drug: Ibuprofen |
| Placebo Tablet | Placebo comparator | Placebo tablets, 2 tablets QID administered with water. Receives: Other: Placebo |
| Ibuprofen Capsule | Active comparator | Ibuprofen 400 mg liquid gel capsules, 2 tablets, TID administered with water Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule
Endoscopic examination of the upper gastrointestinal mucosa evaluated the extent of mucosal injury to the stomach and the duodenum separately using a 5-point Lanza scale, ranging from 0: normal stomach; 1: mucosal hemorrhages; 2: one or two erosions; 3: numerous areas of erosions; and 4: more than 10 erosions or ulcer.
Measured: Day 7
Secondary outcomes (4)
GMD Scores of Paracetamol Tablet; Ibuprofen Capsule; Ibuprofen Tablet; and Placebo Tablet
Endoscopic examination of the upper gastrointestinal mucosa evaluated the extent of mucosal injury to the stomach and the duodenum separately using a 5-point Lanza scale, ranging from 0: normal stomach; 1: mucosal hemorrhages; 2: one or two erosions; 3: numerous areas of erosions; and 4: more than 10 erosions or ulcer.
Measured: Day 7
Duodenal Mucosal Damage (DMD) Scores
DMD was measured using a 5- point Lanza scale: 0 - normal duodenum; 1 - mucosal hemorrhages; 2 - one or two erosions; 3 - numerous areas of erosions and 4 - more than 10 erosions/ ulcers.
Measured: Day 7
Incidence of Gastric and/or Duodenal Mucosal Injury
Number of participants with endoscopy score equal to or more than 2 were determined based on Lanza score for both gastric and duodenal mucosal damage.
Measured: Day 7
Incidence of Fecal Occult Blood
The incidence of fecal occult blood was recorded as a binary response (0 = no presence of blood; 1 = presence of blood).
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startFeb 2012
- Primary completionJul 2012
- Study completionJul 2012
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.
- Other trials for Gastrointestinal Mucosal DamageStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822665
- Sponsor's protocol ID
- A1901106
- Status last verified
- Jul 2013
- First submitted
- 28 Mar 2013
- Last updated
- 31 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Gastrointestinal Safety of OTC Analgesics in Healthy Volunteers by Endoscopic Examination
- ClinicalTrials.gov ID
- NCT01822665
- Acronym / sponsor ID
- A1901106
- Conditions
- Gastrointestinal Mucosal Damage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Posted 31 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Paracetamol Tablet | Active comparator | Drug: ParacetamolParacetamol 500 mg tablet, 2 tablets administered 4 times a day (QID) with water. |
| Ibuprofen Tablet | Active comparator | Drug: IbuprofenIbuprofen 400 mg tablet, 2 tablets administered three times a day (TID) with water |
| Placebo Tablet | Placebo comparator | Other: PlaceboPlacebo tablets, 2 tablets QID administered with water. |
| Ibuprofen Capsule | Active comparator | Drug: IbuprofenIbuprofen 400 mg liquid gel capsules, 2 tablets, TID administered with water |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| IbuprofenLiquid gelation capsules or tablets of 400 mg strength | Drug | Ibuprofen Capsule, Ibuprofen Tablet |
| ParacetamolParacetamol fast dissolving tablets of 500 mg strength | Drug | Paracetamol Tablet |
| PlaceboPlacebo tablets | Other | Placebo Tablet |
Primary outcome
Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule
Time frame: Day 7
Endoscopic examination of the upper gastrointestinal mucosa evaluated the extent of mucosal injury to the stomach and the duodenum separately using a 5-point Lanza scale, ranging from 0: normal stomach; 1: mucosal hemorrhages; 2: one or two erosions; 3: numerous areas of erosions; and 4: more than 10 erosions or ulcer.
4 secondary outcomes
GMD Scores of Paracetamol Tablet; Ibuprofen Capsule; Ibuprofen Tablet; and Placebo Tablet
Time frame: Day 7
Duodenal Mucosal Damage (DMD) Scores
Time frame: Day 7
Incidence of Gastric and/or Duodenal Mucosal Injury
Time frame: Day 7
Incidence of Fecal Occult Blood
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Gastrointestinal Mucosal Damage
RecruitingPhase 2
Study of DONQ52 in Active Celiac Disease
Celiac Disease
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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Ibuprofen and Paracetamol in people with Gastrointestinal Mucosal Damage, run by GlaxoSmithKline 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 3 inclusion and 4 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 31 Mar 2014. 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. Some participants in this study may receive a placebo. 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 31 Mar 2014). 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?
Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule (time frame: Day 7). 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 31 Mar 2014.