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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celecoxib | Experimental |
| |
| Loxoprofen | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug | Celecoxib 100mg tablet twice a day with meal for 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Yokohama | Kanagawa | Japan | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23216412 | Derived | Sakamoto C, Kawai T, Nakamura S, Sugioka T, Tabira J. Comparison of gastroduodenal ulcer incidence in healthy Japanese subjects taking celecoxib or loxoprofen evaluated by endoscopy: a placebo-controlled, double-blind 2-week study. Aliment Pharmacol Ther. 2013 Feb;37(3):346-54. doi: 10.1111/apt.12174. Epub 2012 Dec 10. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Subjects were screened at 3 centers in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Celecoxib | Celecoxib 100 mg tablet twice a day with meal for 2 weeks |
| FG001 | Loxoprofen | Loxoprofen 60 mg tablet three times a day with meal for 2 weeks |
| FG002 | Placebo | Placebo tablet three times a day with meal for 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Celecoxib | Celecoxib 100 mg tablet twice a day with meal for 2 weeks |
| BG001 | Loxoprofen | Loxoprofen 60 mg tablet three times a day with meal for 2 weeks |
| 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 | 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. | 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. | Posted | Number | Percent | 2 weeks |
|
2 weeks
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Celecoxib | Celecoxib 100 mg tablet twice a day with meal for 2 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| C040656 | loxoprofen |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Loxoprofen |
| Drug |
Loxoprofen 60mg tablet three times a day with meal for 2 weeks |
|
| Placebo | Drug | Placebo tablet three times a day with meal for 2 weeks |
|
| Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions | 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. | 2 weeks |
| Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale) | 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) | 2 weeks |
| Number of Gastroduodenal Ulcers in Each Subject | 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.) | 2 weeks |
| Number of Gastroduodenal Erosions in Each Subject | 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.) | 2 weeks |
| Incidence of Treatment-emergent, All-causality GI Body System Adverse Events | 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.) | 2 weeks |
| Minato-ku |
| Tokyo |
| Japan |
| Pfizer Investigational Site | Shinjuku-ku | Tokyo | Japan |
| BG002 | Placebo | Placebo tablet three times a day with meal for 2 weeks |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Helicobacter pylori (H. pylori) status | Number | Participants |
|
Loxoprofen 60 mg tablet three times a day with meal for 2 weeks |
| OG002 | Placebo | Placebo tablet three times a day with meal for 2 weeks |
|
|
|
| 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. | The 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. | Posted | Number | Percent | 2 weeks |
|
|
|
| Secondary | Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions | 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. | The 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. | Posted | Number | Percent | 2 weeks |
|
|
|
| Secondary | Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale) | 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) | The 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. | Posted | Number | Participants | 2 weeks |
|
|
|
| Secondary | Number of Gastroduodenal Ulcers in Each Subject | 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.) | The 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. | Posted | Number | Participants | 2 weeks |
|
|
|
| Secondary | Number of Gastroduodenal Erosions in Each Subject | 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.) | The 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. | Posted | Number | Participants | 2 weeks |
|
|
|
| Secondary | Incidence of Treatment-emergent, All-causality GI Body System Adverse Events | 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.) | The 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. | Posted | Number | Percent | 2 weeks |
|
|
|
| 0 |
| 76 |
| 19 |
| 76 |
| EG001 | Loxoprofen | Loxoprofen 60 mg tablet three times a day with meal for 2 weeks | 0 | 76 | 37 | 76 |
| EG002 | Placebo | Placebo tablet three times a day with meal for 2 weeks | 0 | 37 | 8 | 37 |
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Duodenitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Erosive duodenitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|
|
| Duodenal ulcers and/or erosions |
|
| Title | Measurements |
|---|---|
|
| Score 2 |
|
| Score 3 |
|
| Score 4 |
|
| Score 5 |
|
| Score 6 |
|
| Score 7 |
|
| Title | Measurements |
|---|---|
|
| 2 ulcers |
|
| 3 ulcers |
|
| 4 ulcers |
|
| 5 ulcers |
|
| 6 ulcers |
|
| 7 ulcers |
|
| 8 ulcers |
|
| 9 ulcers |
|
| 10 or more ulcers |
|
| Title | Measurements |
|---|---|
|
| 2 erosions |
|
| 3 erosions |
|
| 4 erosions |
|
| 5 erosions |
|
| 6 erosions |
|
| 7 erosions |
|
| 8 erosions |
|
| 9 erosions |
|
| 10 or more erosions |
|