Trial Outcomes & Findings for Effect of L-dopa In Subacute Back Pain Population (NCT NCT01951105)
NCT ID: NCT01951105
Last Updated: 2021-03-24
Results Overview
Primary outcome is 20% reduction in pain intensity at p\<0.1 based on pain ratings during 1 week prior to treatment and last week of study participation (at \~6months)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
72 participants
Primary outcome timeframe
6 months
Results posted on
2021-03-24
Participant Flow
Participant milestones
| Measure |
Observation
Individuals identified as having a recovering phenotype were assigned to the observational arm and were asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up.
|
Carbidopa/Levodopa & Naproxen
Individuals identified as having a persisting phenotype were randomized to oral Carbidopa/Levodopa on a flexible dose-titration designed intervention based on dose-response throughout the 12 week treatment period (12.5mg/50mg, 25mg/100mg, 50mg/200mg Carbidopa/Levodopa TID).
Naproxen (250mg) capsules were administered orally, one capsule TID, throughout the 12 week treatment period.
|
Placebo & Naproxen
Individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
31
|
30
|
|
Overall Study
Completed 12 Weeks Treatment
|
10
|
24
|
28
|
|
Overall Study
COMPLETED
|
10
|
21
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
10
|
2
|
Reasons for withdrawal
| Measure |
Observation
Individuals identified as having a recovering phenotype were assigned to the observational arm and were asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up.
|
Carbidopa/Levodopa & Naproxen
Individuals identified as having a persisting phenotype were randomized to oral Carbidopa/Levodopa on a flexible dose-titration designed intervention based on dose-response throughout the 12 week treatment period (12.5mg/50mg, 25mg/100mg, 50mg/200mg Carbidopa/Levodopa TID).
Naproxen (250mg) capsules were administered orally, one capsule TID, throughout the 12 week treatment period.
|
Placebo & Naproxen
Individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
1
|
Baseline Characteristics
Data included in the analyses included all participants that completed the study
Baseline characteristics by cohort
| Measure |
Observation
n=10 Participants
Individuals identified as having a recovering phenotype were assigned to the observational arm and were asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up.
|
Carbidopa/Levodopa & Naproxen
n=21 Participants
Individuals identified as having a persisting phenotype were randomized to oral Carbidopa/Levodopa on a flexible dose-titration designed intervention based on dose-response throughout the 12 week treatment period (12.5mg/50mg, 25mg/100mg, 50mg/200mg Carbidopa/Levodopa TID).
Naproxen (250mg) capsules were administered orally, one capsule TID, throughout the 12 week treatment period.
|
Placebo & Naproxen
n=28 Participants
Individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 12.0 • n=5 Participants • Data included in the analyses included all participants that completed the study
|
49.1 years
STANDARD_DEVIATION 10.1 • n=7 Participants • Data included in the analyses included all participants that completed the study
|
46.9 years
STANDARD_DEVIATION 13.2 • n=5 Participants • Data included in the analyses included all participants that completed the study
|
47.5 years
STANDARD_DEVIATION 11.6 • n=4 Participants • Data included in the analyses included all participants that completed the study
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
7 Participants
n=7 Participants • Data included in the analyses included all participants that completed the study
|
14 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
24 Participants
n=4 Participants • Data included in the analyses included all participants that completed the study
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
14 Participants
n=7 Participants • Data included in the analyses included all participants that completed the study
|
14 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
35 Participants
n=4 Participants • Data included in the analyses included all participants that completed the study
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
1 Participants
n=7 Participants • Data included in the analyses included all participants that completed the study
|
6 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
9 Participants
n=4 Participants • Data included in the analyses included all participants that completed the study
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
19 Participants
n=7 Participants • Data included in the analyses included all participants that completed the study
|
20 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
47 Participants
n=4 Participants • Data included in the analyses included all participants that completed the study
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
1 Participants
n=7 Participants • Data included in the analyses included all participants that completed the study
|
2 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
3 Participants
n=4 Participants • Data included in the analyses included all participants that completed the study
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
0 Participants
n=7 Participants • Data included in the analyses included all participants that completed the study
|
0 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
0 Participants
n=4 Participants • Data included in the analyses included all participants that completed the study
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
0 Participants
n=7 Participants • Data included in the analyses included all participants that completed the study
|
0 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
0 Participants
n=4 Participants • Data included in the analyses included all participants that completed the study
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
0 Participants
n=7 Participants • Data included in the analyses included all participants that completed the study
|
0 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
0 Participants
n=4 Participants • Data included in the analyses included all participants that completed the study
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
8 Participants
n=7 Participants • Data included in the analyses included all participants that completed the study
|
10 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
20 Participants
n=4 Participants • Data included in the analyses included all participants that completed the study
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
12 Participants
n=7 Participants • Data included in the analyses included all participants that completed the study
|
17 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
36 Participants
n=4 Participants • Data included in the analyses included all participants that completed the study
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
1 Participants
n=7 Participants • Data included in the analyses included all participants that completed the study
|
1 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
2 Participants
n=4 Participants • Data included in the analyses included all participants that completed the study
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
0 Participants
n=7 Participants • Data included in the analyses included all participants that completed the study
|
0 Participants
n=5 Participants • Data included in the analyses included all participants that completed the study
|
1 Participants
n=4 Participants • Data included in the analyses included all participants that completed the study
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Note that one subject (out of 21) in the Carbidopa/Levodopa \& Naproxen arm, and one subject (out of 28) in the Placebo \& Naproxen arm, had missing NRS pain intensity scale ratings, hence they were excluded from primary outcome assessment.
Primary outcome is 20% reduction in pain intensity at p\<0.1 based on pain ratings during 1 week prior to treatment and last week of study participation (at \~6months)
Outcome measures
| Measure |
Observation
n=10 Participants
Individuals identified as having a recovering phenotype were assigned to the observational arm and were asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up.
|
Carbidopa/Levodopa & Naproxen
n=20 Participants
Individuals identified as having a persisting phenotype were randomized to oral Carbidopa/Levodopa on a flexible dose-titration designed intervention based on dose-response throughout the 12 week treatment period (12.5mg/50mg, 25mg/100mg, 50mg/200mg Carbidopa/Levodopa TID).
Naproxen (250mg) capsules were administered orally, one capsule TID, throughout the 12 week treatment period.
|
Placebo & Naproxen
n=27 Participants
Individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
|
Placebo & Naproxen (Females)
Female individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
|
Observation (Males)
Individuals identified as having a recovering phenotype were assigned to the observational arm and were asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up.
|
Observation (Females)
Individuals identified as having a recovering phenotype were assigned to the observational arm and were asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up.
|
|---|---|---|---|---|---|---|
|
Number of Participants With 20% Reduction in Pain on the NRS Pain Intensity Scale
|
5 Participants
|
15 Participants
|
21 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: This outcome is limited to arms involving medication intake, thus it only concerns to Carbidopa/Levodopa \& Naproxen (males and females) and Placebo \& Naproxen (males and females). It does not include the observation arm. However numbers for the observation arm are also displayed.
Residual pain is computed based on pain ratings from the week prior to treatment and last week of study participation (at \~6months)
Outcome measures
| Measure |
Observation
n=14 Participants
Individuals identified as having a recovering phenotype were assigned to the observational arm and were asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up.
|
Carbidopa/Levodopa & Naproxen
n=6 Participants
Individuals identified as having a persisting phenotype were randomized to oral Carbidopa/Levodopa on a flexible dose-titration designed intervention based on dose-response throughout the 12 week treatment period (12.5mg/50mg, 25mg/100mg, 50mg/200mg Carbidopa/Levodopa TID).
Naproxen (250mg) capsules were administered orally, one capsule TID, throughout the 12 week treatment period.
|
Placebo & Naproxen
n=13 Participants
Individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
|
Placebo & Naproxen (Females)
n=14 Participants
Female individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
|
Observation (Males)
n=7 Participants
Individuals identified as having a recovering phenotype were assigned to the observational arm and were asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up.
|
Observation (Females)
n=3 Participants
Individuals identified as having a recovering phenotype were assigned to the observational arm and were asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up.
|
|---|---|---|---|---|---|---|
|
Percent of Residual Pain Stratified by Gender for Individuals Receiving Treatment
|
62.97 % residual pain
Standard Error 7.57
|
9.48 % residual pain
Standard Error 3.12
|
37.96 % residual pain
Standard Error 11.85
|
45.23 % residual pain
Standard Error 9.86
|
85.55 % residual pain
Standard Error 20.60
|
48.84 % residual pain
Standard Error 30.27
|
Adverse Events
Observation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Carbidopa/Levodopa & Naproxen
Serious events: 3 serious events
Other events: 17 other events
Deaths: 1 deaths
Placebo & Naproxen
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Observation
n=11 participants at risk
Individuals identified as having a recovering phenotype were assigned to the observational arm and were asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up.
|
Carbidopa/Levodopa & Naproxen
n=31 participants at risk
Individuals identified as having a persisting phenotype were randomized to oral Carbidopa/Levodopa on a flexible dose-titration designed intervention based on dose-response throughout the 12 week treatment period (12.5mg/50mg, 25mg/100mg, 50mg/200mg Carbidopa/Levodopa TID).
Naproxen (250mg) capsules were administered orally, one capsule TID, throughout the 12 week treatment period.
|
Placebo & Naproxen
n=30 participants at risk
Individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Esophageal varices
|
0.00%
0/11 • 6 months
|
3.2%
1/31 • 6 months
|
0.00%
0/30 • 6 months
|
|
Cardiac disorders
Worsening angina
|
0.00%
0/11 • 6 months
|
3.2%
1/31 • 6 months
|
0.00%
0/30 • 6 months
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/11 • 6 months
|
3.2%
1/31 • 6 months
|
0.00%
0/30 • 6 months
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/11 • 6 months
|
3.2%
1/31 • 6 months
|
0.00%
0/30 • 6 months
|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
0.00%
0/11 • 6 months
|
3.2%
1/31 • 6 months
|
0.00%
0/30 • 6 months
|
Other adverse events
| Measure |
Observation
n=11 participants at risk
Individuals identified as having a recovering phenotype were assigned to the observational arm and were asked to continue his/her normal regime and return for the week 12 and week 24 visits for follow-up.
|
Carbidopa/Levodopa & Naproxen
n=31 participants at risk
Individuals identified as having a persisting phenotype were randomized to oral Carbidopa/Levodopa on a flexible dose-titration designed intervention based on dose-response throughout the 12 week treatment period (12.5mg/50mg, 25mg/100mg, 50mg/200mg Carbidopa/Levodopa TID).
Naproxen (250mg) capsules were administered orally, one capsule TID, throughout the 12 week treatment period.
|
Placebo & Naproxen
n=30 participants at risk
Individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Upper Gastrointestinal
|
0.00%
0/11 • 6 months
|
19.4%
6/31 • 6 months
|
13.3%
4/30 • 6 months
|
|
Nervous system disorders
Headache
|
0.00%
0/11 • 6 months
|
9.7%
3/31 • 6 months
|
10.0%
3/30 • 6 months
|
|
Gastrointestinal disorders
Lower gastrointestinal
|
0.00%
0/11 • 6 months
|
9.7%
3/31 • 6 months
|
10.0%
3/30 • 6 months
|
|
General disorders
Drowsiness
|
0.00%
0/11 • 6 months
|
9.7%
3/31 • 6 months
|
3.3%
1/30 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory infection
|
0.00%
0/11 • 6 months
|
6.5%
2/31 • 6 months
|
0.00%
0/30 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
0.00%
0/11 • 6 months
|
6.5%
2/31 • 6 months
|
0.00%
0/30 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/11 • 6 months
|
3.2%
1/31 • 6 months
|
10.0%
3/30 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place