Trial Outcomes & Findings for Study of Pyridoxine for Hand-Foot Syndrome (NCT NCT00446147)

NCT ID: NCT00446147

Last Updated: 2014-02-25

Results Overview

A total administered dose of capecitabine until the development of grade 2 or higher hand-foot syndrome during the chemotherapy.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 389 participants
• Primary outcome timeframe: Up to 2 years
• Results posted on: 2014-02-25

Participant Flow

Participant milestones

Measure	Placebo one tablet twice per day, which is identical to pyridoxine Placebo: placebo 100mg BID/daily, Per oral	Pyridoxine 100 mg twice per day Pyridoxine: 100mg BID/daily, Per oral
Overall Study STARTED	195	194
Overall Study COMPLETED	180	180
Overall Study NOT COMPLETED	15	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Pyridoxine for Hand-Foot Syndrome

Baseline characteristics by cohort

Measure	Placebo n=180 Participants one tablet twice per day, which is identical to pyridoxine Placebo: placebo 100mg BID/daily, Per oral	Pyridoxine n=180 Participants 100 mg twice per day Pyridoxine: 100mg BID/daily, Per oral	Total n=360 Participants Total of all reporting groups
Age, Customized Age_median	56 years n=5 Participants	56 years n=7 Participants	56 years n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	59 Participants n=7 Participants	135 Participants n=5 Participants
Sex: Female, Male Male	104 Participants n=5 Participants	121 Participants n=7 Participants	225 Participants n=5 Participants
Region of Enrollment Korea, Republic of	180 participants n=5 Participants	180 participants n=7 Participants	360 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

A total administered dose of capecitabine until the development of grade 2 or higher hand-foot syndrome during the chemotherapy.

Outcome measures

Measure	Placebo n=180 Participants one tablet twice per day, which is identical to pyridoxine Placebo: placebo 100mg BID/daily, Per oral	Pyridoxine n=180 Participants 100 mg twice per day Pyridoxine: 100mg BID/daily, Per oral
Cumulative Dose of Capecitabine Until the Development of Grade 2 or Higher Hand-foot Syndrome	70000 miligram per square meter Interval 69384.0 to 70615.0	70000 miligram per square meter Interval 60010.0 to 79989.0

SECONDARY outcome

Timeframe: Up to 2 years

Number of patients with any grade of hand-foot syndrome

Outcome measures

Measure	Placebo n=180 Participants one tablet twice per day, which is identical to pyridoxine Placebo: placebo 100mg BID/daily, Per oral	Pyridoxine n=180 Participants 100 mg twice per day Pyridoxine: 100mg BID/daily, Per oral
Number of Patients With Hand-foot Syndrome	55 participants	57 participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pyridoxine

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

Dr. Yoon-Koo Kang

Asan Medical Center

Phone: +82-2-3010-3210

Email: ykkang@amc.seoul.kr

Results disclosure agreements

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