Diabetic Neuropathy, Painful
Conditions
Keywords
Diabetic Peripheral Neuropathy
Brief summary
The purpose of the study is to learn if long-term treatment with DVS SR is safe for treating the pain and other symptoms associated with diabetic peripheral neuropathy.
Interventions
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Outpatients who have completed double-blind treatment in study 322 (NCT01050218) for DPN. Subjects must have completed all scheduled evaluations, with no major protocol violations and no events that, in the opinion of the investigator, would preclude the subject's entry into the long-term open-label study. * Women of childbearing potential must have a negative serum pregnancy test on day 91 of the short-term study. A woman of childbearing potential is one who is biologically capable of becoming pregnant. Biologically capable includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Sexually active women participating in the study who are biologically capable of becoming pregnant must use a medically acceptable form of contraception during the study and for at least 15 days after the last dose of test article. Medically acceptable forms of contraception include oral contraceptives, transdermal, injectable, or implantable methods, intrauterine devices, or properly used double-barrier contraception, eg, condom plus diaphragm.
Exclusion criteria
* Presence of any new and/or clinically important medical condition that might compromise subject safety (including, but not limited to, significant changes in glycemic control). * Pregnancy, lactation, or plans to become pregnant during the study. * Use of prohibited treatments. * Meets any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Pain Score on the Numeric Rating Scale (NRS). | Baseline and 9 months | 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. |
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| DVS SR Open Label Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level. | 237 |
| Total | 237 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 37 |
| Overall Study | Compliance | 2 |
| Overall Study | Discontinued by sponsor | 18 |
| Overall Study | Failed to return | 7 |
| Overall Study | Family emergency | 1 |
| Overall Study | Lack of Efficacy | 8 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Serious Adverse Event | 1 |
| Overall Study | Withdrawal by Subject | 18 |
Baseline characteristics
| Characteristic | DVS SR Open Label |
|---|---|
| Age, Continuous | 59.84 years STANDARD_DEVIATION 8.9 |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 173 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 199 / 237 |
| serious Total, serious adverse events | 26 / 237 |
Outcome results
Primary
Change From Baseline in Mean Pain Score on the Numeric Rating Scale (NRS).
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
Population: 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.