Trial Outcomes & Findings for Assessment of Pain in People With Thalassemia (NCT NCT00872339)
NCT ID: NCT00872339
Last Updated: 2014-06-05
Results Overview
Recruitment status
COMPLETED
Target enrollment
252 participants
Primary outcome timeframe
Measured at Month 9
Results posted on
2014-06-05
Participant Flow
Participant milestones
| Measure |
Transfusion-dependant
People with transfusion-dependant thalassemia.
|
Intermittently Transfused
Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
|
Non-transfusion-dependant
People with non-transfusion-dependant thalassemia.
|
|---|---|---|---|
|
Overall Study
STARTED
|
201
|
14
|
37
|
|
Overall Study
COMPLETED
|
201
|
14
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Pain in People With Thalassemia
Baseline characteristics by cohort
| Measure |
Transfusion-dependant
n=201 Participants
People with transfusion-dependant thalassemia.
|
Intermittently Transfused
n=14 Participants
Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
|
Non-transfusion-dependant
n=37 Participants
People with non-transfusion-dependant thalassemia.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28.2 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
29.5 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
28.8 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
137 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 9Outcome measures
| Measure |
Transfusion-dependant
n=201 Participants
People with transfusion-dependant thalassemia.
|
Intermittently Transfused
n=14 Participants
Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
|
Non-transfusion-dependant
n=37 Participants
People with non-transfusion-dependant thalassemia.
|
|---|---|---|---|
|
Prevalence of Pain
|
75 participants
|
7 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Measured at Month 9Outcome measures
| Measure |
Transfusion-dependant
n=93 Participants
People with transfusion-dependant thalassemia.
|
Intermittently Transfused
Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
|
Non-transfusion-dependant
People with non-transfusion-dependant thalassemia.
|
|---|---|---|---|
|
Common Sites of Pain
Lower back
|
76 participants
|
—
|
—
|
|
Common Sites of Pain
Either leg
|
52 participants
|
—
|
—
|
|
Common Sites of Pain
Head
|
45 participants
|
—
|
—
|
|
Common Sites of Pain
Midback
|
44 participants
|
—
|
—
|
|
Common Sites of Pain
Either hip
|
36 participants
|
—
|
—
|
|
Common Sites of Pain
Upper back
|
36 participants
|
—
|
—
|
|
Common Sites of Pain
Either arm
|
29 participants
|
—
|
—
|
|
Common Sites of Pain
Abdomen
|
26 participants
|
—
|
—
|
|
Common Sites of Pain
Chest
|
25 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Month 9Outcome measures
| Measure |
Transfusion-dependant
n=252 Participants
People with transfusion-dependant thalassemia.
|
Intermittently Transfused
Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
|
Non-transfusion-dependant
People with non-transfusion-dependant thalassemia.
|
|---|---|---|---|
|
Pain Occurrence by Age
12-17 yo (n=50)
|
4 participants
|
—
|
—
|
|
Pain Occurrence by Age
18-24 (n=56)
|
19 participants
|
—
|
—
|
|
Pain Occurrence by Age
25-34 (n=61)
|
22 participants
|
—
|
—
|
|
Pain Occurrence by Age
35-44 (n=61)
|
34 participants
|
—
|
—
|
|
Pain Occurrence by Age
45-71 (n=24)
|
14 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Month 9Outcome measures
| Measure |
Transfusion-dependant
n=93 Participants
People with transfusion-dependant thalassemia.
|
Intermittently Transfused
Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
|
Non-transfusion-dependant
People with non-transfusion-dependant thalassemia.
|
|---|---|---|---|
|
Impact of Pain on Functioning and Well-being
Mood
|
83 participants
|
—
|
—
|
|
Impact of Pain on Functioning and Well-being
Normal work
|
76 participants
|
—
|
—
|
|
Impact of Pain on Functioning and Well-being
General activities
|
74 participants
|
—
|
—
|
|
Impact of Pain on Functioning and Well-being
Sleep
|
74 participants
|
—
|
—
|
|
Impact of Pain on Functioning and Well-being
Walking
|
73 participants
|
—
|
—
|
|
Impact of Pain on Functioning and Well-being
Enjoyment of life
|
69 participants
|
—
|
—
|
|
Impact of Pain on Functioning and Well-being
Interpersonal relations
|
57 participants
|
—
|
—
|
Adverse Events
Adverse Events Were Not Collected
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place