Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracetamol Tablet | Active Comparator | Paracetamol 500 mg tablet, 2 tablets administered 4 times a day (QID) with water. |
|
| Ibuprofen Tablet | Active Comparator | Ibuprofen 400 mg tablet, 2 tablets administered three times a day (TID) with water |
|
| Placebo Tablet | Placebo Comparator | Placebo tablets, 2 tablets QID administered with water. |
|
| Ibuprofen Capsule | Active Comparator | Ibuprofen 400 mg liquid gel capsules, 2 tablets, TID administered with water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | Liquid gelation capsules or tablets of 400 mg strength |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Institute for Clinical Research | Houston | Texas | 77074 | United States |
Of 41 participants screened, 12 did not meet the study criterion and one participant withdrew consent. Remaining 28 participants were randomized into the study to received all the four treatments in a sequential manner.
Participants were recruited at the clinical site.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | This was a randomized, 4-way crossover study. Participants received two fast dissolving paracetamol tablets (500 milligrams [mg]/tablet) four times daily (QID); two liquid-filled gelatin capsules containing ibuprofen (200 mg/capsule), three times daily (TID); two ibuprofen tablets (200 mg/tablet), TID; and, two fast dissolving placebo tablets QID. All the treatments were administered orally with water. There was a washout period of 7 days following every treatment session. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Participants | All randomized participants in the study who took at least one treatment dose. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to Treat (ITT) population: all participants who fulfilled all the study entry criteria and receive at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed. | Posted | Mean | Standard Deviation | Scores on a scale | Day 7 |
|
Adverse events were collected from the start of the investigational product, and until 5 days following last administration of the investigational product.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paracetamol Tablet (1000 mg) | Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain upper | Gastrointestinal disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Paracetamol | Drug | Paracetamol fast dissolving tablets of 500 mg strength |
|
| Placebo | Other | Placebo tablets |
|
| 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. | 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. | 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). | Day 7 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| Ibuprofen Capsule (400 mg) |
Two ibuprofen capsules (400 mg/tablet), was administered TID, orally with water. |
|
|
|
| Secondary | 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. | ITT population: All participants who fulfilled all the study entry criteria and received at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed. | Posted | Mean | Standard Deviation | Score on a scale | Day 7 |
|
|
|
|
| Secondary | 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. | ITT population: All participants who fulfilled all the study entry criteria and receive at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed. | Posted | Mean | Standard Deviation | Score on a scale | Day 7 |
|
|
|
|
| Secondary | 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. | ITT population: All participants who fulfilled all the study entry criteria and receive at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed. | Posted | Number | Participants | Day 7 |
|
|
|
|
| Secondary | 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). | ITT population: All participants who fulfilled all the study entry criteria and received at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed. | Posted | Number | Participants | Day 7 |
|
|
|
| 0 |
| 28 |
| 4 |
| 28 |
| EG001 | Ibuprofen Capsule (400 mg) | Two ibuprofen capsules (400 mg/capsule), were administered TID, orally with water. | 0 | 24 | 5 | 24 |
| EG002 | Ibuprofen Tablet (400 mg) | Two ibuprofen tablets (400 mg/tablet), were administered TID, orally with water. | 1 | 23 | 4 | 23 |
| EG003 | Placebo Tablet | Two placebo tablets were administered QID, orally with water. | 0 | 28 | 1 | 23 |
| Diarrhea | Gastrointestinal disorders |
|
| Dyspepsia | Gastrointestinal disorders |
|
| Abdominal Pain Lower | Gastrointestinal disorders |
|
| Duodenal Ulcer | Gastrointestinal disorders |
|
| Flatulence | Gastrointestinal disorders |
|
| Gastritis Erosive | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
|
| Chest Pain | General disorders |
|
| Somnolence | Nervous system disorders |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments. | t-test, 2 sided | Period and treatment were included in the model as fixed effects, while subjects were a random effect. | 0.4794 | No multiple comparisons were carried out. | LS mean difference | 0.19 | 2-Sided | 95 | -0.34 | 0.72 | Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments. | t-test, 2 sided | Period and treatment were included in the model as fixed effects, while subjects were a random effect. | 0.1429 | No multiple comparisons were carried out. | LS mean difference | 0.40 | 2-Sided | 95 | -0.14 | 0.95 | Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments. | t-test, 2 sided | Period and treatment were included in the model as fixed effects, while subjects were a random effect. | <0.0001 | No multiple comparisons were carried out. | LS mean difference | 1.30 | 2-Sided | 95 | 0.75 | 1.84 | Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered no significant difference in mean endoscopy score of gastric mucosal damage between two treatments. | t-test, 2 sided | Period and treatment were included in the model as fixed effects, while subjects were a random effect. | 0.0020 | No multiple comparisons were carried out. | LS mean difference | 0.89 | 2-Sided | 95 | 0.34 | 1.45 | Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments | t-test, 2 sided | Period and treatment were included in the model as fixed effects, while subjects were a random effect. | 0.7591 | No multiple comparisons were carried out. | LS mean difference | -0.06 | 2-Sided | 95 | -0.46 | 0.34 | Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments. | t-test, 2 sided | Period and treatment were included in the model as fixed effects, while subjects were a random effect. | 0.4126 | No multiple comparisons were carried out. | LS mean difference | 0.17 | 2-Sided | 95 | -0.24 | 0.57 | Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments | t-test, 2 sided | Period and treatment were included in the model as fixed effects, while subjects were a random effect. | 0.8903 | No multiple comparisons were carried out. | LS mean difference | 0.03 | 2-Sided | 95 | -0.39 | 0.45 | Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments | t-test, 2 sided | Period and treatment were included in the model as fixed effects, while subjects were a random effect. | 0.2227 | No multiple comparisons were carried out. | LS mean difference | 0.26 | 2-Sided | 95 | -0.16 | 0.67 | Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Null hypothesis considered no significant difference in mean endoscopy score of duodenal mucosal damage between two treatments. | t-test, 2 sided | Period and treatment were included in the model as fixed effects, while subjects were a random effect. | 0.2855 | No multiple comparisons were carried out. | LS mean difference | 0.23 | 2-Sided | 95 | -0.20 | 0.65 | Difference was first named treatment minus second named treatment, such that a positive difference favors the first named treatment. | No | Superiority or Other |
| Chi-squared |
| 0.0999 |
P-value associated with chi-square testing odds ratio. |
| Odds Ratio (OR) |
| 3.19 |
| 2-Sided |
| 95 |
| 0.80 |
| 12.74 |
Odds Ratio from logistic regression model with treatment as factor and period as covariate. |
| No |
| Superiority or Other |
| Chi-squared | 0.2845 | Odds Ratio (OR) | 1.94 | 2-Sided | 95 | 0.58 | 6.50 | Odds Ratio from logistic regression model with treatment as factor and period as covariate. | No | Superiority or Other |
| Score 1 = fecal occult blood present |
|