Trial Outcomes & Findings for Resveratrol Trial for Relief of Pain in Pseudoachondroplasia (NCT NCT03866200)
NCT ID: NCT03866200
Last Updated: 2022-12-09
Results Overview
total score 0-10 with higher scores indicating greater pain
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
baseline, 30 days, 60 days, 90 days
Results posted on
2022-12-09
Participant Flow
Participant milestones
| Measure |
Resveratrol, Then Placebo
Participants first received Resveratrol 125 mg/day or 5 ml daily for 90 days. After a washout period of 30 days, they then received Placebo 5ml daily for 90 days.
resveratrol: 125 mg/day or 5 ml once per day for 90 days Placebo: 5 ml once per day for 90 days
|
Placebo Comparator: Placebo, Then Resveratrol
Participants first received Placebo 5ml daily for 90 days. After a washout period of 30 days, they then received Resveratrol 125 mg/day or 5 ml daily for 90 days.
resveratrol: 125 mg/day or 5 ml once per day for 90 days Placebo: 5 ml once per day for 90 days
|
|---|---|---|
|
First Intervention (90 Days)
STARTED
|
5
|
1
|
|
First Intervention (90 Days)
COMPLETED
|
5
|
1
|
|
First Intervention (90 Days)
NOT COMPLETED
|
0
|
0
|
|
Washout (30 Days)
STARTED
|
5
|
1
|
|
Washout (30 Days)
COMPLETED
|
5
|
1
|
|
Washout (30 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (90 Days)
STARTED
|
5
|
1
|
|
Second Intervention (90 Days)
COMPLETED
|
5
|
1
|
|
Second Intervention (90 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Resveratrol Trial for Relief of Pain in Pseudoachondroplasia
Baseline characteristics by cohort
| Measure |
Resveratrol, Then Placebo
n=5 Participants
Participants first received Resveratrol 125 mg/day or 5 ml daily for 90 days. After a washout period of 30 days, they then received Placebo 5ml daily for 90 days.
resveratrol: 125 mg/day or 5 ml once per day for 90 days
|
Placebo, Then Resveratrol
n=1 Participants
Participants first received Placebo 5ml daily for 90 days. After a washout period of 30 days, they then received Resveratrol 125 mg/day or 5 ml daily for 90 days.
Placebo: 5 ml once per day for 90 days
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.2 years
STANDARD_DEVIATION 16.36 • n=93 Participants
|
49 years
STANDARD_DEVIATION 0 • n=4 Participants
|
51.67 years
STANDARD_DEVIATION 14.69 • n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=93 Participants
|
1 participants
n=4 Participants
|
6 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: baseline, 30 days, 60 days, 90 daysPopulation: Data were not collected for one participant
total score 0-10 with higher scores indicating greater pain
Outcome measures
| Measure |
Resveratrol
n=5 Participants
Participants who received Resveratrol 125 mg/day or 5 ml daily either the first or last 90 days of the study
|
Placebo
n=5 Participants
Participants who received Placebo 5ml daily for either the first or last 90 days of the study.
|
|---|---|---|
|
Pain as Assessed by Numeric Pain Rating Scale
Baseline
|
3.60 score on a scale
Standard Deviation 1.36
|
3.60 score on a scale
Standard Deviation 1.36
|
|
Pain as Assessed by Numeric Pain Rating Scale
30 days
|
2.72 score on a scale
Standard Deviation 1.24
|
2.36 score on a scale
Standard Deviation 1.00
|
|
Pain as Assessed by Numeric Pain Rating Scale
60 days
|
2.44 score on a scale
Standard Deviation 1.36
|
2.10 score on a scale
Standard Deviation 1.09
|
|
Pain as Assessed by Numeric Pain Rating Scale
90 days
|
2.55 score on a scale
Standard Deviation 0.92
|
1.92 score on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: baseline, 30 days, 60 days, 90 daystotal score 0-100 with higher scores indicating better outcome
Outcome measures
| Measure |
Resveratrol
n=6 Participants
Participants who received Resveratrol 125 mg/day or 5 ml daily either the first or last 90 days of the study
|
Placebo
n=6 Participants
Participants who received Placebo 5ml daily for either the first or last 90 days of the study.
|
|---|---|---|
|
Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36)
Baseline
|
68.60 score on a scale
Standard Deviation 13.06
|
68.60 score on a scale
Standard Deviation 13.06
|
|
Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36)
30 days
|
76.30 score on a scale
Standard Deviation 11.23
|
75.84 score on a scale
Standard Deviation 13.78
|
|
Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36)
60 days
|
70.17 score on a scale
Standard Deviation 16.56
|
80.33 score on a scale
Standard Deviation 13.46
|
|
Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36)
90 days
|
76.71 score on a scale
Standard Deviation 14.27
|
77.54 score on a scale
Standard Deviation 14.34
|
Adverse Events
Resveratrol
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
Karen Posey, PhD
The University of Texas Health Science Center at Houston
Phone: 713-500-5786
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place