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D-cycloserine in the Management of Chronic Low Back Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00125528
First Posted: August 1, 2005
Last Update Posted: February 9, 2017
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.
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University
Results First Submitted: February 3, 2015  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
D-cycloserine D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
Placebo placebo: placebo bid

Participant Flow:   Overall Study
    D-cycloserine   Placebo
STARTED   20   21 
COMPLETED   18   20 
NOT COMPLETED   2   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
D-cycloserine D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
Placebo placebo: placebo bid
Total Total of all reporting groups

Baseline Measures
   D-cycloserine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   21   41 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.65  (11.56)   54.76  (10.84)   54.71  (11.06) 
Gender 
[Units: Participants]
Count of 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 6.47  (1.40)   6.6  (1.50)   6.54  (1.45) 
[1] 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.


  Outcome Measures
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1.  Primary:   Change in Numeric Rating Scale (NRS-11)   [ Time Frame: 6 weeks ]

2.  Secondary:   McGill Pain Questionnaire (MPQ)   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: tjs@northwestern.edu


Publications of Results:

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