Study Of Celecoxib In Healthy Subjects

A Randomized, Placebo-Controlled, Double-Blind, Phase 4 Study To Compare The Effect Of Celecoxib 100 Mg BID, Loxoprofen 60 Mg TID And Placebo On The Gastroduodenal Mucosa In Healthy Subjects

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00994461

Enrollment

190

Registered

2009-10-14

Start date

2009-11-30

Completion date

2010-04-30

Last updated

2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Endoscopy

Brief summary

A study to confirm the superiority of celecoxib 100 mg BID to loxoprofen 60 mg TID in the incidence of gastroduodenal endoscopic ulcers after 2 weeks treatment.

Interventions

DRUGCelecoxib

Celecoxib 100mg tablet twice a day with meal for 2 weeks

DRUGLoxoprofen

Loxoprofen 60mg tablet three times a day with meal for 2 weeks

DRUGPlacebo

Placebo tablet three times a day with meal for 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 74 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy Volunteers

Exclusion criteria

* Endoscopic evidence of ulceration, erosion or active bleeding etc. in the esophagus, stomach, pylorus and/or duodenum prior to treatment endoscopy * A history of gastrointestinal ulcer * Any use of celecoxib, nonsteroidal anti-inflammatory drugs (including aspirin), anti-ulcer medication, antacids, systemic steroids or antibiotics within four weeks prior to the first dose of study medication

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Gastroduodenal Ulcers	2 weeks	The percentage of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.

Secondary

Measure	Time frame	Description
Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions	2 weeks	The percentage of subjects who had gastroduodenal, gastric, and duodenal endoscopic ulcers and/or erosions after 2 weeks treatment (The number of subjects who had gastroduodenal, gastric, and duodenal endoscopic ulcers and/or erosions after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth. An erosion is defined as a lesion producing a definite break in the mucosa with equivocal depth.
Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)	2 weeks	Number of subjects for each gastroduodenal endoscopic score (according to Mucosal Grading Scale) after 2 weeks treatment (Score 0 = normal mucosa (no visible lesions); Score 1 = 1 to 10 petechiae; Score 2 = more than 10 petechiae; Score 3 = 1 to 5 erosions; Score 4 = 6 to 10 erosions; Score 5 = 11 to 25 erosions; Score 6 = more than 25 erosions; Score 7 = ulcer)
Incidence of Any Gastric, and Duodenal Ulcers	2 weeks	The percentage of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.
Number of Gastroduodenal Erosions in Each Subject	2 weeks	Number of subjects for each number of gastroduodenal endoscopic erosions after 2 weeks treatment (An erosion is defined as a lesion producing a definite break in the mucosa with equivocal depth.)
Incidence of Treatment-emergent, All-causality GI Body System Adverse Events	2 weeks	The percentage of subjects who had treatment-emergent, all-causality gastrointestinal body system adverse events after 2 weeks treatment (The number of subjects who had treatment-emergent, all-causality gastrointestinal body system adverse events after 2 weeks treatment divided by participants multiplied by 100.)
Number of Gastroduodenal Ulcers in Each Subject	2 weeks	Number of subjects for each number of gastroduodenal endoscopic ulcers after 2 weeks treatment (An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.)

Countries

Japan

Participant flow

Recruitment details

Subjects were screened at 3 centers in Japan.

Participants by arm

Arm	Count
Celecoxib Celecoxib 100 mg tablet twice a day with meal for 2 weeks	76
Loxoprofen Loxoprofen 60 mg tablet three times a day with meal for 2 weeks	76
Placebo Placebo tablet three times a day with meal for 2 weeks	37
Total	189

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	2	1	0

Baseline characteristics

Characteristic	Celecoxib	Loxoprofen	Placebo	Total
Age, Continuous	56.5 Years STANDARD_DEVIATION 9.65	57.8 Years STANDARD_DEVIATION 9.38	59.1 Years STANDARD_DEVIATION 9.18	57.5 Years STANDARD_DEVIATION 9.45
Helicobacter pylori (H. pylori) status Negative	44 Participants	43 Participants	21 Participants	108 Participants
Helicobacter pylori (H. pylori) status Positive	32 Participants	33 Participants	16 Participants	81 Participants
Sex: Female, Male Female	54 Participants	55 Participants	26 Participants	135 Participants
Sex: Female, Male Male	22 Participants	21 Participants	11 Participants	54 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	19 / 76	37 / 76	8 / 37
serious Total, serious adverse events	0 / 76	0 / 76	0 / 37

Outcome results

Primary

Incidence of Gastroduodenal Ulcers

The percentage of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.

Time frame: 2 weeks

Population: The modified-safety analysis set (m-SAF) consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.

Arm	Measure	Value (NUMBER)
Celecoxib	Incidence of Gastroduodenal Ulcers	1.4 Percent
Loxoprofen	Incidence of Gastroduodenal Ulcers	27.6 Percent
Placebo	Incidence of Gastroduodenal Ulcers	2.7 Percent

Comparison: Hypothesis testing was conducted with significant p-value level of under 0.05.p-value: <0.0001Cochran-Mantel-Haenszel

Secondary

Incidence of Any Gastric, and Duodenal Ulcers

The percentage of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.

Time frame: 2 weeks