Trial Outcomes & Findings for Effect of Celecoxib on Perioperative Inflammatory Response in Colon Cancer (NCT NCT01284504)

NCT ID: NCT01284504

Last Updated: 2018-03-16

Results Overview

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

2 years

Results posted on

2018-03-16

Participant Flow

1 patient was consented but withdrew before treatment assignment (randomization), none were treated.

Participant milestones

Participant milestones
Measure	Celocoxib Celecoxib: 200 mg tablet oral	Placebo placebo placebo
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Celecoxib on Perioperative Inflammatory Response in Colon Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Celecoxib n=1 Participants Celecoxib, 200 mg tab Celecoxib: 200 mg tablet oral	Placebo placebo, tab placebo: Placebo, tab	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	—	1 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	—	1 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	—	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Region of Enrollment United States	1 participants n=93 Participants	—	1 participants n=27 Participants

PRIMARY outcome

Timeframe: 2 years

Population: One patient was accrued and withdrawn after signing consent; none were treated.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 30 days

Population: One patient was accrued and withdrawn after signing consent; none were treated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Population: One patient was accrued and withdrawn after signing consent; none were treated.

Outcome measures

Outcome data not reported

Adverse Events

Celecoxib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anthony Doufas, MD, PhD

Stanford University

Phone: 1-650-498-7699

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place