An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT00736853
First received: August 14, 2008
Last updated: July 22, 2013
Last verified: July 2013
Results First Received: April 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pain
Interventions: Drug: Tramadol Hydrochloride Plus Acetaminophen (Open-Label)
Drug: Tramadol Hydrochloride Plus Acetaminophen (Double-Blind)
Drug: Placebo (Double-Blind)

  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
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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
Tramadol Hydrochloride and Acetaminophen (Open-Label) Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets).
Tramadol Hydrochloride and Acetaminophen (Double-Blind) Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks.
Placebo (Double-Blind) Matching placebo was given up to 4 weeks.

Participant Flow for 2 periods

Period 1:   Open-Label Period
    Tramadol Hydrochloride and Acetaminophen (Open-Label)     Tramadol Hydrochloride and Acetaminophen (Double-Blind)     Placebo (Double-Blind)  
STARTED     319     0     0  
Treated     277     0     0  
COMPLETED     187     0     0  
NOT COMPLETED     132     0     0  
Physician Decision                 2                 0                 0  
Adverse Event                 31                 0                 0  
Withdrawal by Subject                 16                 0                 0  
Started but not treated                 42                 0                 0  
Failed to meet the transfer criteria                 40                 0                 0  
Unable to attend hospital appointments                 1                 0                 0  

Period 2:   Double-Blind Period
    Tramadol Hydrochloride and Acetaminophen (Open-Label)     Tramadol Hydrochloride and Acetaminophen (Double-Blind)     Placebo (Double-Blind)  
STARTED     0     94     93  
COMPLETED     0     70     45  
NOT COMPLETED     0     24     48  
Lack of Efficacy                 0                 19                 42  
Adverse Event                 0                 3                 2  
Withdrawal by Subject                 0                 1                 4  
Ineligible to participate the study                 0                 1                 0  



  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.
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Reporting Groups
  Description
Entire Study Population Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets) during the open-label period. Participants received placebo or fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg (same dose which was used in second week of open-label period) in double-blind period.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  277  
Age [1]
[units: years]
Mean ± Standard Deviation
  57.0  ± 17.5  
Gender [1]
[units: participants]
 
Female     168  
Male     109  
[1] Efficacy analysis set: Participants who received at least 1 dose of study drug.



  Outcome Measures
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1.  Primary:   Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period   [ Time Frame: Day 28 of double-blind period ]

2.  Secondary:   Change in the Visual Analog Scale for the Last 24 Hours (VAS24) Value at the Start of the Double-Blind Period From the Baseline Value at the Start of the Open-Label Period   [ Time Frame: Day 1 of open-label period and Day 1 of double-blind period ]

3.  Secondary:   Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period   [ Time Frame: Day 1 and Day 28 of double-blind period ]

4.  Secondary:   Mean Pain Intensity (PI) Score During Open-Label Period   [ Time Frame: Pre-dose and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period ]

5.  Secondary:   Mean PI Score During Double-Blind Period   [ Time Frame: Pre-dose and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period ]

6.  Secondary:   Mean Pain Intensity Difference (PID) During the Open-Label Period   [ Time Frame: Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period ]

7.  Secondary:   Mean PID During the Double-Blind Period   [ Time Frame: Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period ]

8.  Secondary:   Mean Pain Relief (PAR) Score During the Open-Label Period   [ Time Frame: 2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period ]

9.  Secondary:   Mean PAR Score During the Double-Blind Period   [ Time Frame: 2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period ]

10.  Secondary:   Pain Intensity Difference and Pain Relief Scores (PRID) During the Open-Label Period   [ Time Frame: 2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period ]

11.  Secondary:   Pain Intensity Difference and Pain Relief Scores (PRID) During the Double-Blind Period   [ Time Frame: 2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period ]

12.  Secondary:   Sum of Pain Intensity Difference (SPID) Score During the Open-Label Period   [ Time Frame: Day 1, and Day 8 of open-label period ]

13.  Secondary:   Sum of Pain Intensity Difference (SPID) Score During the Double-Blind Period   [ Time Frame: Day 1, 8, 15, 22 and 28 of double-blind period ]

14.  Secondary:   Total Pain Relief (TOTPAR) Score During the Open-Label Period   [ Time Frame: Day 1 and Day 8 of open-label period ]

15.  Secondary:   Total Pain Relief (TOTPAR) Score During the Double-Blind Period   [ Time Frame: Day 1, 8, 15, 22 and 28 of double-blind period ]

16.  Secondary:   Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Open-Label Period   [ Time Frame: Day 1, and Day 8 of open-label period ]

17.  Secondary:   Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Double-Blind Period   [ Time Frame: Day 1, 8, 15, 22 and 28 of double-blind period ]

18.  Secondary:   Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Total Score at Day 14 of Open-Label Period   [ Time Frame: Day 1 and Day 14 of open-label period ]

19.  Secondary:   Change From Baseline in RDQ Total Score at Day 28 of Double-Blind Period   [ Time Frame: Day 1 and Day 28 of double-blind period ]

20.  Secondary:   Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire Score at Day 14 of Open-Label Period   [ Time Frame: Day 1 and Day 14 of open-label period ]

21.  Secondary:   Change From Baseline in WOMAC Questionnaire Score at Day 28 of Double-Blind Period   [ Time Frame: Day 1 and Day 28 of double-blind period ]

22.  Secondary:   Change From Baseline in Short Form-36 (SF-36) Score at Day 14 of Open-Label Period   [ Time Frame: Day 1 and Day 14 of open-label period ]

23.  Secondary:   Change From Baseline in SF-36 at Day 28 of Double-Blind Period   [ Time Frame: Day 1 and Day 28 of double-blind period ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Neuroscience Department, Clinical Science Division, R&D, JANSSEN PHARMACEUTICAL. K.K.
phone: +81-3-4411-5509


No publications provided


Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT00736853     History of Changes
Other Study ID Numbers: CR015112, JNS013-JPN-04
Study First Received: August 14, 2008
Results First Received: April 12, 2013
Last Updated: July 22, 2013
Health Authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center
Japan: Pharmaceuticals and Medical Devices Agency