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Trial record 67 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

D-cycloserine in the Management of Chronic Low Back Pain

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: NCT00125528
Recruitment Status : Completed
First Posted : August 1, 2005
Results First Posted : February 23, 2015
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Low Back Pain
Pain
Interventions Drug: D-cycloserine
Drug: placebo
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid placebo: placebo bid
Period Title: Overall Study
Started 20 21
Completed 18 20
Not Completed 2 1
Arm/Group Title D-cycloserine Placebo Total
Hide Arm/Group Description D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid placebo: placebo bid Total of all reporting groups
Overall Number of Baseline Participants 20 21 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 21 participants 41 participants
54.65  (11.56) 54.76  (10.84) 54.71  (11.06)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
Female
14
  70.0%
11
  52.4%
25
  61.0%
Male
6
  30.0%
10
  47.6%
16
  39.0%
Numeric Rating Scale (NRS-11)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 21 participants 41 participants
6.47  (1.40) 6.6  (1.50) 6.54  (1.45)
[1]
Measure Description: Numeric rating scale is an 11-point rating scale wherein participants rated their current lower back pain intensity on a scale from 0 to 10, with 0 meaning no pain and 10 being the worst pain possible. Thus, a lower score represents a better pain state at baseline.
1.Primary Outcome
Title Change in Numeric Rating Scale (NRS-11)
Hide Description Change in NRS score after 6 weeks of treatment as compared to baseline. The numeric rating scale is an 11-point rating scale wherein participants rated their current lower back pain intensity on a scale from 0 to 10, with 0 meaning no pain and 10 being the worst pain possible. Thus, a larger negative number indicates positive change and a higher efficacy.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
placebo: placebo bid
Overall Number of Participants Analyzed 18 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.47  (0.50) -1.55  (0.50)
2.Secondary Outcome
Title McGill Pain Questionnaire (MPQ)
Hide Description Change in MPQ score after 6 weeks of treatment as compared to baseline. The MPQ score uses a Pain Rating Index from 0 to 20 where 0 is evidence of no pain and 20 indicates the highest pain possible. A lower score is also indicative of a lower quality of pain. Thus, a larger negative number indicates positive change and therefore higher efficacy.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description:
D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
placebo: placebo bid
Overall Number of Participants Analyzed 18 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.80  (0.66) -1.00  (0.66)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title D-cycloserine Placebo
Hide Arm/Group Description D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid placebo: placebo bid
All-Cause Mortality
D-cycloserine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
D-cycloserine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
D-cycloserine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/20 (15.00%)      5/21 (23.81%)    
General disorders     
Headache   1/20 (5.00%)  1 3/21 (14.29%)  3
Nervous system disorders     
Numbness/Tingling   3/20 (15.00%)  3 0/21 (0.00%)  0
Skin and subcutaneous tissue disorders     
Lower Extremity Edema   0/20 (0.00%)  0 2/21 (9.52%)  2
Indicates events were collected by systematic assessment
It is not clear whether observed effects are due to escalating dose or duration of D-cycloserine use. A larger population and longer duration of treatment would be needed to determine this.
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
Name/Title: Dr. Thomas Schnitzer
Organization: Northwestern Universiyt
Phone: 312-503-2315
Responsible Party: Thomas J. Schnitzer, Northwestern University
ClinicalTrials.gov Identifier: NCT00125528     History of Changes
Other Study ID Numbers: A1159
First Submitted: July 29, 2005
First Posted: August 1, 2005
Results First Submitted: February 3, 2015
Results First Posted: February 23, 2015
Last Update Posted: February 9, 2017