Trial Outcomes & Findings for A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain (NCT NCT01675050)
NCT ID: NCT01675050
Last Updated: 2017-08-30
Results Overview
Increasing pressures were applied with a pressure plunger to the participants' thumbnail. The pressure at which the participant said that s/he felt pain is noted. The pressure is measured in kilograms by centimeters squared.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
at 4 weeks of cyproheptadine or placebo treatment
Results posted on
2017-08-30
Participant Flow
Participant milestones
| Measure |
Cyproheptadine First, Then Placebo
4 weeks of cyproheptadine with crossover to 4 weeks of placebo.
|
Sugar Pill First, Than Cyproheptadine
4 weeks of placebo (sugar pill) with crossover to 4 weeks of cyproheptadine
|
|---|---|---|
|
Period One Treatment
STARTED
|
2
|
2
|
|
Period One Treatment
COMPLETED
|
1
|
2
|
|
Period One Treatment
NOT COMPLETED
|
1
|
0
|
|
Wash Out Period
STARTED
|
1
|
2
|
|
Wash Out Period
COMPLETED
|
1
|
2
|
|
Wash Out Period
NOT COMPLETED
|
0
|
0
|
|
Second Period Treatment
STARTED
|
1
|
2
|
|
Second Period Treatment
COMPLETED
|
1
|
2
|
|
Second Period Treatment
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cyproheptadine First, Then Placebo
4 weeks of cyproheptadine with crossover to 4 weeks of placebo.
|
Sugar Pill First, Than Cyproheptadine
4 weeks of placebo (sugar pill) with crossover to 4 weeks of cyproheptadine
|
|---|---|---|
|
Period One Treatment
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Because 1 participant on the Cyproheptadine first side dropped out prior to assignment to placebo, there is only 1 participant shown on the cyproheptadine first then placebo side for the second baseline after washout prior to placebo.
Baseline characteristics by cohort
| Measure |
Cyproheptadine Then Placebo
n=2 Participants
4 weeks of cyproheptadine with crossover to 4 weeks of placebo.
|
Placebo Then Cyproheptadine
n=2 Participants
4 weeks of placebo (sugar pill) with crossover to 4 weeks of cyproheptadine
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.5 years
n=2 Participants
|
10.5 years
n=2 Participants
|
11.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
|
Pressure Pain Threshold
Baseline prior to First Treatment
|
1.75 kg/cm^2
STANDARD_DEVIATION 2 • n=2 Participants • Because 1 participant on the Cyproheptadine first side dropped out prior to assignment to placebo, there is only 1 participant shown on the cyproheptadine first then placebo side for the second baseline after washout prior to placebo.
|
1.28 kg/cm^2
STANDARD_DEVIATION .53 • n=2 Participants • Because 1 participant on the Cyproheptadine first side dropped out prior to assignment to placebo, there is only 1 participant shown on the cyproheptadine first then placebo side for the second baseline after washout prior to placebo.
|
1.51 kg/cm^2
STANDARD_DEVIATION .99 • n=4 Participants • Because 1 participant on the Cyproheptadine first side dropped out prior to assignment to placebo, there is only 1 participant shown on the cyproheptadine first then placebo side for the second baseline after washout prior to placebo.
|
|
Pressure Pain Threshold
Baseline prior to Second Treatment
|
1.25 kg/cm^2
STANDARD_DEVIATION 0 • n=1 Participants • Because 1 participant on the Cyproheptadine first side dropped out prior to assignment to placebo, there is only 1 participant shown on the cyproheptadine first then placebo side for the second baseline after washout prior to placebo.
|
1.08 kg/cm^2
STANDARD_DEVIATION .18 • n=2 Participants • Because 1 participant on the Cyproheptadine first side dropped out prior to assignment to placebo, there is only 1 participant shown on the cyproheptadine first then placebo side for the second baseline after washout prior to placebo.
|
1.13 kg/cm^2
STANDARD_DEVIATION .16 • n=3 Participants • Because 1 participant on the Cyproheptadine first side dropped out prior to assignment to placebo, there is only 1 participant shown on the cyproheptadine first then placebo side for the second baseline after washout prior to placebo.
|
|
Improvement in Abdominal Pain
Baseline prior to First Treatment
|
4 units on a scale
STANDARD_DEVIATION 5.66 • n=2 Participants • Because 1 participant in the Cyproheptadine first group withdrew prior to washout, that participant's data is not included in the pre-placebo period baseline.
|
8.5 units on a scale
STANDARD_DEVIATION 2.12 • n=2 Participants • Because 1 participant in the Cyproheptadine first group withdrew prior to washout, that participant's data is not included in the pre-placebo period baseline.
|
6.25 units on a scale
STANDARD_DEVIATION 4.35 • n=4 Participants • Because 1 participant in the Cyproheptadine first group withdrew prior to washout, that participant's data is not included in the pre-placebo period baseline.
|
|
Improvement in Abdominal Pain
Baseline prior to Second Treatment
|
6 units on a scale
STANDARD_DEVIATION 0 • n=1 Participants • Because 1 participant in the Cyproheptadine first group withdrew prior to washout, that participant's data is not included in the pre-placebo period baseline.
|
6.5 units on a scale
STANDARD_DEVIATION 3.45 • n=2 Participants • Because 1 participant in the Cyproheptadine first group withdrew prior to washout, that participant's data is not included in the pre-placebo period baseline.
|
6.33 units on a scale
STANDARD_DEVIATION 2.52 • n=3 Participants • Because 1 participant in the Cyproheptadine first group withdrew prior to washout, that participant's data is not included in the pre-placebo period baseline.
|
PRIMARY outcome
Timeframe: at 4 weeks of cyproheptadine or placebo treatmentIncreasing pressures were applied with a pressure plunger to the participants' thumbnail. The pressure at which the participant said that s/he felt pain is noted. The pressure is measured in kilograms by centimeters squared.
Outcome measures
| Measure |
All Participants Post Cyproheptadine
n=4 Participants
|
All Participants Post Placebo
n=3 Participants
|
|---|---|---|
|
Pressure Pain Threshold
|
1.15 kg/cm^2
Standard Deviation .73
|
1.23 kg/cm^2
Standard Deviation .39
|
SECONDARY outcome
Timeframe: 10 weeksParticipants rated the highest intensity of abdominal pain they experienced during the past two weeks on a scale of 0 (No Pain) to 10 (The Most Pain Possible), as derived from the "Abdominal Pain Index - Child Version" (Laird et al. 2015. Journal of Pediatric Psychology, 40(5), 517-525).
Outcome measures
| Measure |
All Participants Post Cyproheptadine
n=4 Participants
|
All Participants Post Placebo
n=3 Participants
|
|---|---|---|
|
Abdominal Pain
|
5.25 units on a scale
Standard Deviation 4.11
|
8 units on a scale
Standard Deviation 2
|
Adverse Events
Cyproheptadine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cyproheptadine
n=4 participants at risk
All participants while on Cyproheptadine.
|
Placebo
n=3 participants at risk
All participants while on Placebo.
|
|---|---|---|
|
General disorders
Increase Appetite
|
25.0%
1/4 • 10 weeks during study
|
33.3%
1/3 • 10 weeks during study
|
|
Nervous system disorders
Somnolence (Drowsiness)
|
50.0%
2/4 • 10 weeks during study
|
33.3%
1/3 • 10 weeks during study
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • 10 weeks during study
|
0.00%
0/3 • 10 weeks during study
|
|
Vascular disorders
Cold Sweats
|
25.0%
1/4 • 10 weeks during study
|
0.00%
0/3 • 10 weeks during study
|
|
Psychiatric disorders
Restless Sleeping Pattern
|
25.0%
1/4 • 10 weeks during study
|
0.00%
0/3 • 10 weeks during study
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
25.0%
1/4 • 10 weeks during study
|
0.00%
0/3 • 10 weeks during study
|
|
Psychiatric disorders
Trouble Sleeping (Insomnia)
|
25.0%
1/4 • 10 weeks during study
|
0.00%
0/3 • 10 weeks during study
|
Additional Information
Ismaeel Hashemi, M.D. Principal Investigator
University of Michigan
Phone: 6169165566
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place