NCT01822665

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 2, 2013

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 31, 2014

Completed
Last Updated

March 31, 2014

Status Verified

July 1, 2013

Enrollment Period

5 months

First QC Date

March 28, 2013

Results QC Date

June 20, 2013

Last Update Submit

February 13, 2014

Conditions

Gastrointestinal Mucosal Damage

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 7

Secondary Outcomes (4)

  • GMD Scores of Paracetamol Tablet; Ibuprofen Capsule; Ibuprofen Tablet; and Placebo Tablet

    Day 7

  • Duodenal Mucosal Damage (DMD) Scores

    Day 7

  • Incidence of Gastric and/or Duodenal Mucosal Injury

    Day 7

  • Incidence of Fecal Occult Blood

    Day 7

Study Arms (4)

Paracetamol Tablet

ACTIVE COMPARATOR

Paracetamol 500 mg tablet, 2 tablets administered 4 times a day (QID) with water.

Drug: Paracetamol

Ibuprofen Tablet

ACTIVE COMPARATOR

Ibuprofen 400 mg tablet, 2 tablets administered three times a day (TID) with water

Drug: Ibuprofen

Placebo Tablet

PLACEBO COMPARATOR

Placebo tablets, 2 tablets QID administered with water.

Other: Placebo

Ibuprofen Capsule

ACTIVE COMPARATOR

Ibuprofen 400 mg liquid gel capsules, 2 tablets, TID administered with water

Drug: Ibuprofen

Interventions

IbuprofenDRUG

Liquid gelation capsules or tablets of 400 mg strength

Ibuprofen CapsuleIbuprofen Tablet
ParacetamolDRUG

Paracetamol fast dissolving tablets of 500 mg strength

Paracetamol Tablet
PlaceboOTHER

Placebo tablets

Placebo Tablet

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Houston Institute for Clinical Research

Houston, Texas, 77074, United States

Location

MeSH Terms

Interventions

IbuprofenAcetaminophen

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2013

First Posted

April 2, 2013

Study Start

February 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

March 31, 2014

Results First Posted

March 31, 2014

Record last verified: 2013-07

Locations

US(1)