ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Evaluating Desvenlafaxine Succinate Sustained-release (DVS SR) in Adult Outpatients With Pain Associated With Diabetic Peripheral Neuropathy

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: NCT00283842
Recruitment Status : Terminated (business reasons)
First Posted : January 30, 2006
Results First Posted : August 13, 2009
Last Update Posted : October 24, 2011
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diabetic Neuropathies
Pain
Interventions: Drug: DVS SR
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited January 2006 to February 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were screened during a 7- to 28-day period, a treatment period.

Reporting Groups
  Description
Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg 50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg 100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg 200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg 400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
Placebo No text entered.

Participant Flow:   Overall Study
    Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg   Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg   Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg   Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg   Placebo
STARTED   63   87   99   69   90 
COMPLETED   51   69   68   42   75 
NOT COMPLETED   12   18   31   27   15 
Adverse Event                8                7                21                21                5 
Protocol Violation                1                5                4                0                0 
Protocol deviation                0                0                0                0                2 
Withdrawal by Subject                2                1                1                5                4 
Lack of Efficacy                1                3                1                0                3 
Lost to Follow-up                0                2                4                1                1 



  Baseline Characteristics

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
Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg 50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg 100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg 200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg 400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
   Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg   Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg   Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg   Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 63   87   99   69   90   408 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.62  (8.59)   60.66  (9.23)   59.80  (9.38)   61.14  (10.03)   58.98  (8.51)   60.31  (9.16) 
Gender 
[Units: Participants]
           
Female   16   20   30   17   25   108 
Male   47   67   69   52   65   300 


  Outcome Measures

1.  Primary:   Change in Mean Pain Severity Score From Baseline to 13 Weeks   [ Time Frame: Baseline and 13 weeks ]

2.  Secondary:   Number of Patients With ≥50% Reduction in Mean Pain Severity Score.   [ Time Frame: Baseline and 13 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: U.S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00283842     History of Changes
Other Study ID Numbers: 3151A5-322
First Submitted: January 26, 2006
First Posted: January 30, 2006
Results First Submitted: June 30, 2009
Results First Posted: August 13, 2009
Last Update Posted: October 24, 2011