Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of L-dopa In Subacute Back Pain Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01951105
Recruitment Status : Completed
First Posted : September 26, 2013
Results First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Apkar Apkarian, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Sub-acute Back Pain
Interventions Drug: Naproxen
Drug: Carbidopa/Levodopa
Drug: Placebo
Enrollment 72
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Observation Carbidopa/Levodopa & Naproxen Placebo & Naproxen
Hide Arm/Group Description 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.

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.

Individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
Period Title: Overall Study
Started 11 31 30
Completed 12 Weeks Treatment 10 24 28
Completed 10 21 28
Not Completed 1 10 2
Reason Not Completed
Adverse Event             0             5             0
Lost to Follow-up             0             1             0
Protocol Violation             1             1             1
Withdrawal by Subject             0             3             1
Arm/Group Title Observation Carbidopa/Levodopa & Naproxen Placebo & Naproxen Total
Hide Arm/Group Description 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.

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.

Individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 10 21 28 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 21 participants 28 participants 59 participants
45.5  (12.0) 49.1  (10.1) 46.9  (13.2) 47.5  (11.6)
[1]
Measure Analysis Population Description: Data included in the analyses included all participants that completed the study
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 21 participants 28 participants 59 participants
Female
3
  30.0%
7
  33.3%
14
  50.0%
24
  40.7%
Male
7
  70.0%
14
  66.7%
14
  50.0%
35
  59.3%
[1]
Measure Analysis Population Description: Data included in the analyses included all participants that completed the study
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 21 participants 28 participants 59 participants
Hispanic or Latino
2
  20.0%
1
   4.8%
6
  21.4%
9
  15.3%
Not Hispanic or Latino
8
  80.0%
19
  90.5%
20
  71.4%
47
  79.7%
Unknown or Not Reported
0
   0.0%
1
   4.8%
2
   7.1%
3
   5.1%
[1]
Measure Analysis Population Description: Data included in the analyses included all participants that completed the study
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 21 participants 28 participants 59 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  20.0%
8
  38.1%
10
  35.7%
20
  33.9%
White
7
  70.0%
12
  57.1%
17
  60.7%
36
  61.0%
More than one race
0
   0.0%
1
   4.8%
1
   3.6%
2
   3.4%
Unknown or Not Reported
1
  10.0%
0
   0.0%
0
   0.0%
1
   1.7%
[1]
Measure Analysis Population Description: Data included in the analyses included all participants that completed the study
1.Primary Outcome
Title Number of Participants With 20% Reduction in Pain on the NRS Pain Intensity Scale
Hide Description 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)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Observation Carbidopa/Levodopa & Naproxen Placebo & Naproxen
Hide Arm/Group Description:
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.

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.

Individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
Overall Number of Participants Analyzed 10 20 27
Measure Type: Count of Participants
Unit of Measure: Participants
5
  50.0%
15
  75.0%
21
  77.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Carbidopa/Levodopa & Naproxen, Placebo & Naproxen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Percent of Residual Pain Stratified by Gender for Individuals Receiving Treatment
Hide Description Residual pain is computed based on pain ratings from the week prior to treatment and last week of study participation (at ~6months)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Carbidopa/Levodopa & Naproxen (Males) Carbidopa/Levodopa & Naproxen (Females) Placebo & Naproxen (Males) Placebo & Naproxen (Females) Observation (Males) Observation (Females)
Hide Arm/Group Description:

Male 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.

Female 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.

Male individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
Female individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
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.
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.
Overall Number of Participants Analyzed 14 6 13 14 7 3
Mean (Standard Error)
Unit of Measure: % residual pain
62.97  (7.57) 9.48  (3.12) 37.96  (11.85) 45.23  (9.86) 85.55  (20.60) 48.84  (30.27)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Observation Carbidopa/Levodopa & Naproxen Placebo & Naproxen
Hide Arm/Group Description 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.

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.

Individuals identified as having a persisting phenotype were randomized to placebo capsule plus 250mg naproxen tablet TID for 12 weeks.
All-Cause Mortality
Observation Carbidopa/Levodopa & Naproxen Placebo & Naproxen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   1/31 (3.23%)   0/30 (0.00%) 
Hide Serious Adverse Events
Observation Carbidopa/Levodopa & Naproxen Placebo & Naproxen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   3/31 (9.68%)   0/30 (0.00%) 
Cardiac disorders       
Worsening angina   0/11 (0.00%)  1/31 (3.23%)  0/30 (0.00%) 
Coronary artery disease   0/11 (0.00%)  1/31 (3.23%)  0/30 (0.00%) 
Gastrointestinal disorders       
Esophageal varices   0/11 (0.00%)  1/31 (3.23%)  0/30 (0.00%) 
Pregnancy, puerperium and perinatal conditions       
Pregnancy   0/11 (0.00%)  1/31 (3.23%)  0/30 (0.00%) 
Miscarriage   0/11 (0.00%)  1/31 (3.23%)  0/30 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Observation Carbidopa/Levodopa & Naproxen Placebo & Naproxen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   17/31 (54.84%)   14/30 (46.67%) 
Gastrointestinal disorders       
Upper Gastrointestinal   0/11 (0.00%)  6/31 (19.35%)  4/30 (13.33%) 
Lower gastrointestinal   0/11 (0.00%)  3/31 (9.68%)  3/30 (10.00%) 
General disorders       
Drowsiness   0/11 (0.00%)  3/31 (9.68%)  1/30 (3.33%) 
Nervous system disorders       
Headache   0/11 (0.00%)  3/31 (9.68%)  3/30 (10.00%) 
Respiratory, thoracic and mediastinal disorders       
Lower respiratory infection   0/11 (0.00%)  2/31 (6.45%)  0/30 (0.00%) 
Influenza   0/11 (0.00%)  2/31 (6.45%)  0/30 (0.00%) 
Upper respiratory infection   0/11 (0.00%)  1/31 (3.23%)  3/30 (10.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Apkar Vania Apkarian
Organization: Northwestern University
Phone: 312-503-0404
EMail: a-apkarian@northwestern.edu
Layout table for additonal information
Responsible Party: Apkar Apkarian, Northwestern University
ClinicalTrials.gov Identifier: NCT01951105    
Other Study ID Numbers: STU00081444
R01DE022746 ( U.S. NIH Grant/Contract )
First Submitted: September 17, 2013
First Posted: September 26, 2013
Results First Submitted: June 4, 2019
Results First Posted: September 25, 2019
Last Update Posted: September 25, 2019