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Trial record 15 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

Study Evaluating the Long-Term Safety of Desvenlafaxine Succinate Sustained-Release (DVS SR) in Subjects 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: NCT01050218
Recruitment Status : Terminated (Business reasons)
First Posted : January 15, 2010
Results First Posted : May 11, 2010
Last Update Posted : July 20, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetic Neuropathy, Painful
Intervention Drug: Desvenlafaxine Succinate Sustained-Release (DVS SR)
Enrollment 237
Recruitment Details Patients were recruited in the United States from July 2006 to September 2008.
Pre-assignment Details Outpatients must have completed double-blind treatment and all scheduled evaluations in study 3151A5-322 (NCT00283842), with no major protocol violations and no events that, in the opinion of the investigator, would have precluded the subject’s entry into the long-term open-label study.
Arm/Group Title DVS SR Open Label
Hide Arm/Group Description Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
Period Title: Overall Study
Started 237
Completed 142
Not Completed 95
Reason Not Completed
Adverse Event             37
Lack of Efficacy             8
Protocol Violation             3
Withdrawal by Subject             18
Discontinued by sponsor             18
Compliance             2
Failed to return             7
Serious Adverse Event             1
Family emergency             1
Arm/Group Title DVS SR Open Label
Hide Arm/Group Description Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
Overall Number of Baseline Participants 237
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 237 participants
59.84  (8.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 237 participants
Female
64
  27.0%
Male
173
  73.0%
1.Primary Outcome
Title Change From Baseline in Mean Pain Score on the Numeric Rating Scale (NRS).
Hide Description The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain. The primary efficacy evaluation was the change from baseline in mean pain score on the NRS.
Time Frame Baseline and 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy population was the intent-to-treat (ITT). This included all randomized subjects who had a baseline primary efficacy evaluation, had taken at least 1 dose of test article, and had at least 1 primary efficacy evaluation (ie, at least 1 NRS daily pain score) after the first dose of test article. No participants met that criterion.
Arm/Group Title DVS SR Open Label
Hide Arm/Group Description:
Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DVS SR Open Label
Hide Arm/Group Description Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
All-Cause Mortality
DVS SR Open Label
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DVS SR Open Label
Affected / at Risk (%)
Total   26/237 (10.97%) 
Blood and lymphatic system disorders   
Iron deficiency anaemia *  1/237 (0.42%) 
Cardiac disorders   
Angina pectoris *  1/237 (0.42%) 
Atrial fibrillation *  1/237 (0.42%) 
Bradycardia *  1/237 (0.42%) 
Cardiac failure congestive *  3/237 (1.27%) 
Diastolic dysfunction *  1/237 (0.42%) 
Gastrointestinal disorders   
Abdominal hernia *  1/237 (0.42%) 
Diarrhoea *  1/237 (0.42%) 
Erosive oesophagitis *  1/237 (0.42%) 
Gastrointestinal haemorrhage *  1/237 (0.42%) 
Intestinal obstruction *  2/237 (0.84%) 
Nausea *  3/237 (1.27%) 
Vomiting *  2/237 (0.84%) 
General disorders   
Asthenia *  1/237 (0.42%) 
Chest pain *  3/237 (1.27%) 
Oedema peripheral *  1/237 (0.42%) 
Hepatobiliary disorders   
Cholelithiasis *  1/237 (0.42%) 
Infections and infestations   
Cellulitis *  1/237 (0.42%) 
Diverticulitis *  1/237 (0.42%) 
Localised infection *  2/237 (0.84%) 
Pneumonia *  1/237 (0.42%) 
Injury, poisoning and procedural complications   
Overdose *  1/237 (0.42%) 
Investigations   
Blood glucose fluctuation *  1/237 (0.42%) 
Blood glucose increased *  1/237 (0.42%) 
Blood pressure increased *  1/237 (0.42%) 
Metabolism and nutrition disorders   
Dehydration *  1/237 (0.42%) 
Diabetes mellitus inadequate control *  1/237 (0.42%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal chest pain *  1/237 (0.42%) 
Spondylolisthesis *  1/237 (0.42%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Malignant melanoma in situ *  1/237 (0.42%) 
Nervous system disorders   
Haemorrhage intracranial *  1/237 (0.42%) 
Headache *  2/237 (0.84%) 
Status epilepticus *  1/237 (0.42%) 
Syncope *  1/237 (0.42%) 
Psychiatric disorders   
Mental status changes *  2/237 (0.84%) 
Renal and urinary disorders   
Nephrolithiasis *  1/237 (0.42%) 
Renal failure acute *  1/237 (0.42%) 
Urinary retention *  1/237 (0.42%) 
Reproductive system and breast disorders   
Ovarian mass *  1/237 (0.42%) 
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease *  1/237 (0.42%) 
Hiccups *  1/237 (0.42%) 
Pulmonary hypertension *  1/237 (0.42%) 
Vascular disorders   
Iliac artery stenosis *  1/237 (0.42%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DVS SR Open Label
Affected / at Risk (%)
Total   199/237 (83.97%) 
Ear and labyrinth disorders   
Ear and labyrinth disorders general *  12/237 (5.06%) 
Eye disorders   
Eye disorders general *  13/237 (5.49%) 
Gastrointestinal disorders   
Diarrhoea *  12/237 (5.06%) 
Dry mouth *  15/237 (6.33%) 
Nausea *  23/237 (9.70%) 
Vomiting *  16/237 (6.75%) 
General disorders   
Fatigue *  13/237 (5.49%) 
Infections and infestations   
Nasopharyngitis *  19/237 (8.02%) 
Upper respiratory tract infection *  24/237 (10.13%) 
Injury, poisoning and procedural complications   
Injury, poisoning and procedural complications general *  46/237 (19.41%) 
Investigations   
Investigations general *  38/237 (16.03%) 
Metabolism and nutrition disorders   
Metabolism and nutrition disorders general *  20/237 (8.44%) 
Musculoskeletal and connective tissue disorders   
Arthralgia *  14/237 (5.91%) 
Back pain *  12/237 (5.06%) 
Muscle spasms *  13/237 (5.49%) 
Nervous system disorders   
Dizziness *  39/237 (16.46%) 
Headache *  18/237 (7.59%) 
Psychiatric disorders   
Psychiatric disorders general *  35/237 (14.77%) 
Renal and urinary disorders   
Renal and urinary disorders general *  28/237 (11.81%) 
Reproductive system and breast disorders   
Reproductive system and breast disorders general *  13/237 (5.49%) 
Respiratory, thoracic and mediastinal disorders   
Respiratory, thoracic and mediastinal disorders general *  26/237 (10.97%) 
Skin and subcutaneous tissue disorders   
Skin and subcutaneous tissue disorders general *  37/237 (15.61%) 
Vascular disorders   
Hypertension *  19/237 (8.02%) 
*
Indicates events were collected by non-systematic assessment
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 PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: U. S. Contact Center
Organization: Wyeth
EMail: clintrialresults@wyeth.com
Layout table for additonal information
Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT01050218     History of Changes
Other Study ID Numbers: 3151A5-325
First Submitted: January 13, 2010
First Posted: January 15, 2010
Results First Submitted: January 29, 2010
Results First Posted: May 11, 2010
Last Update Posted: July 20, 2010