Trial Outcomes & Findings for Evaluation of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children (NCT NCT00694564)

Results Overview

We scored the Wong-Baker Pain Rating Scale numerically on a scale of 0 (no pain) to 4 (worst pain).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

0, 2 weeks, 1 month, 2 months

Results posted on

2018-03-16

Participant Flow

Participant milestones

Participant milestones
Measure	SAM-e This an open-labeled study. All participants received SAM-e. S-adenosyl methionine : All participants received oral SAM-e which was initiated at a dose of 200 mg daily and escalated by 200 mg every week to a maximum dose of 1400 mg daily if patients did not report significant resolution of abdominal pain (defined as reduction in reported pain and to a maximum frequency of once weekly).
Overall Study STARTED	8
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sam-e (Treatment) n=8 Participants This an open-labeled study. All participants will be part of the treatment group and receive SAM-e. S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.
Age, Categorical <=18 years	8 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	14 years STANDARD_DEVIATION 2 • n=99 Participants
Sex: Female, Male Female	6 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Region of Enrollment United States	8 participants n=99 Participants

PRIMARY outcome

Timeframe: 0, 2 weeks, 1 month, 2 months

We scored the Wong-Baker Pain Rating Scale numerically on a scale of 0 (no pain) to 4 (worst pain).

Outcome measures

Outcome measures
Measure	SAM-e n=6 Participants This an open-labeled study. All participants will receive SAM-e. S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.
Wong-Baker FACES Pain Rating Scale Wong-Baker FACES Pain Rating Scale (2-months)	3 units on a scale Standard Deviation 0
Wong-Baker FACES Pain Rating Scale Wong-Baker FACES Pain Rating Scale (1-month)	3 units on a scale Standard Deviation 0
Wong-Baker FACES Pain Rating Scale Wong-Baker FACES Pain Rating Scale (2 weeks)	4 units on a scale Standard Deviation 1
Wong-Baker FACES Pain Rating Scale Wong-Baker FACES Pain Rating Scale (baseline)	4 units on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 0, 2 weeks, 1 month, 2 month

Assessments of liver transaminases and alkaline phosphatasewere performed at baseline, 2 weeks, 1 month and 2 months. Depression and mania were assessed weekly.

Outcome measures

Outcome data not reported

Adverse Events

Sam-e (Treatment)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sam-e (Treatment) n=8 participants at risk This an open-labeled study. All participants will be part of the treatment group and receive SAM-e. S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.
Nervous system disorders headaches	87.5% 7/8
Hepatobiliary disorders Alkaline Phosphatase Decrease	12.5% 1/8

Additional Information

Dr. Jeannie Huang

UC San Diego

Phone: 858-576-1700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place