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Trial Outcomes & Findings for Gastrointestinal Integrity After Naproxen + Rebamipide Versus Naproxen + Placebo (NCT NCT02632812)

NCT ID: NCT02632812

Last Updated: 2017-03-20

Results Overview

Cryer score according to gastroduodenal mucosal injury: 0 = Normal or erythema 1. = Any amount of submucosal hemorrhage or edema without erosions 2. = 1 erosion +- submucosal hemorrhage or edema 3. = 2-4 erosions +- submucosal hemorrhage or edema 4. = 5 or more erosions and/or a single ulcer +- submucosal hemorrhage or edema 5. = Multiple ulcers +- submucosal hemorrhage or edema - Ulcer

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

8 days

Results posted on

2017-03-20

Participant Flow

Participant milestones

Participant milestones
Measure
Rebamipide 200 mg
Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) Rebamipide effervescent granules Naproxen tablet
Placebo
Placebo effervescent granules (oral) Twice daily Placebo effervescent granules Naproxen tablet
Overall Study
STARTED
12
12
Overall Study
COMPLETED
12
12
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gastrointestinal Integrity After Naproxen + Rebamipide Versus Naproxen + Placebo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Rebamipide 200 mg
n=12 Participants
Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) Rebamipide effervescent granules Naproxen tablet
Placebo
n=12 Participants
Placebo effervescent granules (oral) Twice daily Placebo effervescent granules Naproxen tablet
Total
n=24 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
12 Participants
n=5 Participants
12 Participants
n=7 Participants
24 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
23.5 years
n=5 Participants
28.5 years
n=7 Participants
24.5 years
n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
6 Participants
n=7 Participants
12 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
6 Participants
n=7 Participants
12 Participants
n=5 Participants
Region of Enrollment
Brazil
12 participants
n=5 Participants
12 participants
n=7 Participants
24 participants
n=5 Participants

PRIMARY outcome

Timeframe: 8 days

Population: All recruited volunteers completed the trial.

Cryer score according to gastroduodenal mucosal injury: 0 = Normal or erythema 1. = Any amount of submucosal hemorrhage or edema without erosions 2. = 1 erosion +- submucosal hemorrhage or edema 3. = 2-4 erosions +- submucosal hemorrhage or edema 4. = 5 or more erosions and/or a single ulcer +- submucosal hemorrhage or edema 5. = Multiple ulcers +- submucosal hemorrhage or edema - Ulcer

Outcome measures

Outcome measures
Measure
Rebamipide & Naproxen
n=12 Participants
Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days
Placebo & Naproxen
n=12 Participants
Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days
Endoscopic Score - Cryer Score
4 Cryer score
Interval 0.0 to 5.0
4 Cryer score
Interval 0.0 to 5.0

PRIMARY outcome

Timeframe: 8 days

Modified Lanza score according to gastroduodenal mucosal injury: 0 = No hemorrhage or erosion observed 1. = One or two hemorrhages or erosions observed in one gastric area 2. = Three to five hemorrhages or erosions observed in one gastric area 3. = Hemorrhages or erosions observed in two gastric areas, six or more hemorrhages or erosions observed in one gastric area, with the total number not exceeding ten in the entire stomach 4. = Hemorrhages or erosions observed in three or more gastric areas; eleven or more hemorrhages or erosions observed widely in the entire stomach 5. = Ulcer

Outcome measures

Outcome measures
Measure
Rebamipide & Naproxen
n=12 Participants
Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days
Placebo & Naproxen
n=12 Participants
Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days
Endoscopic Score - Modified Lanza Score
3.5 Modified Lanza score
Interval 0.0 to 5.0
4 Modified Lanza score
Interval 0.0 to 5.0

PRIMARY outcome

Timeframe: 8 days

Histopathologic grade score developed for microscopic injury evaluation 0 = Normal gastric mucosa or mild chronic inflammation 1. = Chronic gastritis without activity 2. = Chronic gastritis with activity on antrum 3. = Chronic gastritis with activity on the body 4. = Chronic gastritis with activity on antrum and on the body

Outcome measures

Outcome measures
Measure
Rebamipide & Naproxen
n=12 Participants
Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days
Placebo & Naproxen
n=12 Participants
Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days
Histopathological Score
Basal endoscopy
1 Histopathologic grade score
Interval 0.0 to 4.0
1 Histopathologic grade score
Interval 0.0 to 4.0
Histopathological Score
End of treatment endoscopy
1 Histopathologic grade score
Interval 0.0 to 4.0
1 Histopathologic grade score
Interval 0.0 to 4.0

PRIMARY outcome

Timeframe: 8 days

Population: Intragastric PH measurement was not performed and for this reason it will not be available.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 8 days

Giemsa stain was used to diagnose H. pylori (positive = presence of H. pylori)

Outcome measures

Outcome measures
Measure
Rebamipide & Naproxen
n=12 Participants
Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days
Placebo & Naproxen
n=12 Participants
Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days
Presence of H. Pylori by Biopsy
Basal endoscopy
5 participants
5 participants
Presence of H. Pylori by Biopsy
End of treatment endoscopy
6 participants
6 participants

PRIMARY outcome

Timeframe: 8 days

Tissue prostaglandin concentration quantified by enzyme-linked immunosorbent assay (ELISA) using Cayman Chemical Monoclonal Prostaglandin E2 EIA Kit (item number 514010)

Outcome measures

Outcome measures
Measure
Rebamipide & Naproxen
n=12 Participants
Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days
Placebo & Naproxen
n=12 Participants
Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days
Prostaglandin Level (PGE2 Quantification)
Basal PGE2 concentration
999 pg/mL (mean tissue PGE2 concentration)
Interval 890.0 to 1108.0
1005 pg/mL (mean tissue PGE2 concentration)
Interval 876.0 to 1134.0
Prostaglandin Level (PGE2 Quantification)
End of treatment PGE2 concentration
168 pg/mL (mean tissue PGE2 concentration)
Interval 155.0 to 181.0
241 pg/mL (mean tissue PGE2 concentration)
Interval 200.0 to 282.0

SECONDARY outcome

Timeframe: 60 days

Outcome measures

Outcome measures
Measure
Rebamipide & Naproxen
n=12 Participants
Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days
Placebo & Naproxen
n=12 Participants
Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days
Number of Adverse Events
7 adverse events
7 adverse events

Adverse Events

Rebamipide 200 mg

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Rebamipide 200 mg
n=12 participants at risk
Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) Rebamipide effervescent granules Naproxen tablet
Placebo
n=12 participants at risk
Placebo effervescent granules (oral) Twice daily Placebo effervescent granules Naproxen tablet
Gastrointestinal disorders
Addominal distress
0.00%
0/12
8.3%
1/12 • Number of events 2
Gastrointestinal disorders
Abdominal pain
8.3%
1/12 • Number of events 2
16.7%
2/12 • Number of events 2
Gastrointestinal disorders
Heartburn
16.7%
2/12 • Number of events 3
0.00%
0/12

Additional Information

Gilberto De Nucci, PhD, principal investigator

Galeno Desenvolvimento de Pesquisas Ltda.

Phone: 55.19.32516928

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place