Diabetic Neuropathies, Pain
Conditions
Keywords
neuropathic pain, diabetic peripheral neuropathy
Brief summary
The purpose of this study is to evaluate the safety and efficacy of DVS SR in the treatment of neuropathic pain associated with diabetic peripheral neuropathy.
Interventions
DRUGDVS SR
DRUGPlacebo
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diabetes type 1 or 2 * Painful symptoms of diabetic neuropathy in the lower extremities extremities for at least 6 months
Exclusion criteria
* Major Depression * Uncontrolled diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Pain Severity Score From Baseline to 13 Weeks | Baseline and 13 weeks | Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Change: score at 13 weeks minus score at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With ≥50% Reduction in Mean Pain Severity Score. | Baseline and 13 weeks | Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Assessment of reduction based on change in score at 13 weeks compared to baseline. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited January 2006 to February 2008
Pre-assignment details
Participants were screened during a 7- to 28-day period, a treatment period.
Participants by arm
| Arm | Count |
|---|---|
| Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg 50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 63 |
| Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg 100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 87 |
| Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg 200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 99 |
| Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg 400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally | 69 |
| Placebo | 90 |
| Total | 408 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 8 | 7 | 21 | 21 | 5 |
| Overall Study | Lack of Efficacy | 1 | 3 | 1 | 0 | 3 |
| Overall Study | Lost to Follow-up | 0 | 2 | 4 | 1 | 1 |
| Overall Study | Protocol deviation | 0 | 0 | 0 | 0 | 2 |
| Overall Study | Protocol Violation | 1 | 5 | 4 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 1 | 5 | 4 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|---|
| Age Continuous | 61.62 years STANDARD_DEVIATION 8.59 | 60.66 years STANDARD_DEVIATION 9.23 | 59.80 years STANDARD_DEVIATION 9.38 | 61.14 years STANDARD_DEVIATION 10.03 | 58.98 years STANDARD_DEVIATION 8.51 | 60.31 years STANDARD_DEVIATION 9.16 |
| Sex: Female, Male Female | 16 Participants | 20 Participants | 30 Participants | 17 Participants | 25 Participants | 108 Participants |
| Sex: Female, Male Male | 47 Participants | 67 Participants | 69 Participants | 52 Participants | 65 Participants | 300 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 47 / — | 65 / — | 82 / — | 63 / — | 68 / — |
| serious Total, serious adverse events | 1 / — | 1 / — | 1 / — | 3 / — | 6 / — |
Outcome results
Primary
Change in Mean Pain Severity Score From Baseline to 13 Weeks
Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Change: score at 13 weeks minus score at baseline.
Time frame: Baseline and 13 weeks
Population: The analysis population was the intent to treat.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg | Change in Mean Pain Severity Score From Baseline to 13 Weeks | -2.41 units on scale | Standard Error 0.26 |
| Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg | Change in Mean Pain Severity Score From Baseline to 13 Weeks | -2.42 units on scale | Standard Error 0.23 |
| Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg | Change in Mean Pain Severity Score From Baseline to 13 Weeks | -2.93 units on scale | Standard Error 0.22 |
| Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg | Change in Mean Pain Severity Score From Baseline to 13 Weeks | -2.74 units on scale | Standard Error 0.27 |
| Placebo | Change in Mean Pain Severity Score From Baseline to 13 Weeks | -1.83 units on scale | Standard Error 0.22 |
Comparison: Statistical analysis provided for 50mg.p-value: 0.084Hochberg
Comparison: Statistical analysis provided for 100mg.p-value: 0.084Hochberg
Comparison: Statistical analysis provided for 200mg.p-value: 0.001Hochberg
Comparison: Statistical analysis provided for 400mg.p-value: 0.027Hochberg
Secondary
Number of Patients With ≥50% Reduction in Mean Pain Severity Score.
Pain severity measured on a Numeric Rating Scale (NRS). Range: 0 (no pain) to 10 (worst possible pain). Assessment of reduction based on change in score at 13 weeks compared to baseline.
Time frame: Baseline and 13 weeks
Population: The analysis population is the intent to treat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg | Number of Patients With ≥50% Reduction in Mean Pain Severity Score. | 22 patients |
| Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg | Number of Patients With ≥50% Reduction in Mean Pain Severity Score. | 32 patients |
| Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg | Number of Patients With ≥50% Reduction in Mean Pain Severity Score. | 36 patients |
| Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg | Number of Patients With ≥50% Reduction in Mean Pain Severity Score. | 22 patients |
| Placebo | Number of Patients With ≥50% Reduction in Mean Pain Severity Score. | 23 patients |
Comparison: Statistical analysis provided for 50mg.p-value: 0.375Hochberg
Comparison: Statistical analysis provided for 100mg.p-value: 0.342Hochberg
Comparison: Statistical analysis provided for 200mg.p-value: 0.342Hochberg
Comparison: Statistical analysis provided for 400mg.p-value: 0.375Hochberg