Diabetic Neuropathies
Conditions
Brief summary
The purpose of the study is to investigate safety and efficacy of duloxetine for patients with painful diabetic neuropathy at long-term use.
Interventions
DRUGDuloxetine hydrochloride
Duloxetine 40 mg QD, PO, 1 year
Sponsors
Shionogi
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Outpatients who have completed the 13-week treatment in the preceding study (Protocol No. 0715N0831: NCT00552175). * Patients who desire to receive continued treatment with LY248686 from the preceding study. * Patients with latest glycosylated hemoglobin (HbA1c) ≤9.0% before Visit 7. * Patients who can provide written consent in person.
Exclusion criteria
* Patients who concurrently have serious cardiovascular, hepatic, renal, respiratory, or blood disease, or symptomatic peripheral vascular disease, and thus are considered inappropriate to be included in the study. * Pregnant patients or women who desire to become pregnant during the study period, and breast feeding patients. * Other patients judged by the investigator/subinvestigator to be inappropriate as a subject in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced an Adverse Event (AE) | baseline through 1 year | See the Reported Adverse Events section for details. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale | baseline, 1 year | A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). |
| Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint | 1 year | A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. |
| Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores | baseline, 1 year | A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now. |
| Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint. | 1 year | A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). |
| Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores | baseline, 1 year | Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes). |
| Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint | 1 year | A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. |
| Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score | baseline, 1 year | A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. |
| Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint | 1 year | Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes). |
Countries
Japan
Participant flow
Recruitment details
This study, F1J-JE-HMFY (Study HMFY), is an open-label, long-term extension study of double-blind placebo-controlled study F1J-JE-HMFX (Study HMFX) (NCT00552175).
Pre-assignment details
Prior to start of extension study (HMFY), all participants in Study HMFX were re-randomized to duloxetine 40 or 60 mg regardless of the treatment they received in Study HMFX. Baseline values for the extension study HMFY represent those of 40- and 60-mg groups after re-randomization of participants.
Participants by arm
| Arm | Count |
|---|---|
| Duloxetine 40 mg Duloxetine 40 mg once daily (QD), orally (PO), 1 year | 129 |
| Duloxetine 60 mg Duloxetine 60 mg QD, PO, 1 year | 129 |
| Total | 258 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 24 | 29 |
| Overall Study | Lack of Efficacy | 1 | 2 |
| Overall Study | Reason Not Specified | 1 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Duloxetine 40 mg | Duloxetine 60 mg | Total |
|---|---|---|---|
| Age Continuous | 60.2 years STANDARD_DEVIATION 10.5 | 60.0 years STANDARD_DEVIATION 9.6 | 60.1 years STANDARD_DEVIATION 10 |
| Beck Depression Inventory - II (BDI-II) | 6.1 units on a scale STANDARD_DEVIATION 6.4 | 6.1 units on a scale STANDARD_DEVIATION 6.4 | 6.1 units on a scale STANDARD_DEVIATION 6.4 |
| Body Mass Index (BMI) | 23.79 kilograms/meters squared (kg/m^2) STANDARD_DEVIATION 3.77 | 23.77 kilograms/meters squared (kg/m^2) STANDARD_DEVIATION 3.49 | 23.78 kilograms/meters squared (kg/m^2) STANDARD_DEVIATION 3.62 |
| Brief Pain Inventory (BPI) Interference Average Interference Score | 2.14 units on a scale STANDARD_DEVIATION 2.09 | 2.32 units on a scale STANDARD_DEVIATION 2.06 | 2.23 units on a scale STANDARD_DEVIATION 2.07 |
| Brief Pain Inventory (BPI) Interference Enjoyment of Life | 1.9 units on a scale STANDARD_DEVIATION 2.1 | 2.1 units on a scale STANDARD_DEVIATION 2.1 | 2.0 units on a scale STANDARD_DEVIATION 2.1 |
| Brief Pain Inventory (BPI) Interference General Activity | 2.5 units on a scale STANDARD_DEVIATION 2.4 | 2.7 units on a scale STANDARD_DEVIATION 2.2 | 2.6 units on a scale STANDARD_DEVIATION 2.3 |
| Brief Pain Inventory (BPI) Interference Mood | 2.3 units on a scale STANDARD_DEVIATION 2.3 | 2.4 units on a scale STANDARD_DEVIATION 2.2 | 2.3 units on a scale STANDARD_DEVIATION 2.2 |
| Brief Pain Inventory (BPI) Interference Normal Work | 2.3 units on a scale STANDARD_DEVIATION 2.3 | 2.3 units on a scale STANDARD_DEVIATION 2.2 | 2.3 units on a scale STANDARD_DEVIATION 2.3 |
| Brief Pain Inventory (BPI) Interference Relation to People | 1.6 units on a scale STANDARD_DEVIATION 2.1 | 1.9 units on a scale STANDARD_DEVIATION 2.1 | 1.8 units on a scale STANDARD_DEVIATION 2.1 |
| Brief Pain Inventory (BPI) Interference Sleep | 2.2 units on a scale STANDARD_DEVIATION 2.3 | 2.5 units on a scale STANDARD_DEVIATION 2.4 | 2.3 units on a scale STANDARD_DEVIATION 2.4 |
| Brief Pain Inventory (BPI) Interference Walking Ability | 2.2 units on a scale STANDARD_DEVIATION 2.4 | 2.3 units on a scale STANDARD_DEVIATION 2.1 | 2.3 units on a scale STANDARD_DEVIATION 2.2 |
| Brief Pain Inventory (BPI) - Pain Severity Average Pain | 3.8 units on a scale STANDARD_DEVIATION 1.9 | 4.0 units on a scale STANDARD_DEVIATION 1.9 | 3.9 units on a scale STANDARD_DEVIATION 1.9 |
| Brief Pain Inventory (BPI) - Pain Severity Least Pain | 2.8 units on a scale STANDARD_DEVIATION 2 | 3.1 units on a scale STANDARD_DEVIATION 2.1 | 3.0 units on a scale STANDARD_DEVIATION 2 |
| Brief Pain Inventory (BPI) - Pain Severity Pain Right Now | 3.4 units on a scale STANDARD_DEVIATION 2.1 | 3.6 units on a scale STANDARD_DEVIATION 2.1 | 3.5 units on a scale STANDARD_DEVIATION 2.1 |
| Brief Pain Inventory (BPI) - Pain Severity Worst Pain | 4.7 units on a scale STANDARD_DEVIATION 2 | 4.9 units on a scale STANDARD_DEVIATION 2 | 4.8 units on a scale STANDARD_DEVIATION 2 |
| Duration of Diabetes 5 to 10 Years | 27 participants | 23 participants | 50 participants |
| Duration of Diabetes Greater Than or Equal to 10 Years | 76 participants | 79 participants | 155 participants |
| Duration of Diabetes Less Than 5 Years | 23 participants | 25 participants | 48 participants |
| Duration of Diabetes Unknown | 3 participants | 2 participants | 5 participants |
| Duration of Diabetic Neuropathy | 3.91 years STANDARD_DEVIATION 3.16 | 4.29 years STANDARD_DEVIATION 3.91 | 4.10 years STANDARD_DEVIATION 3.55 |
| Height | 163.69 centimeters (cm) STANDARD_DEVIATION 9.04 | 165.12 centimeters (cm) STANDARD_DEVIATION 7.75 | 164.41 centimeters (cm) STANDARD_DEVIATION 8.44 |
| Patient's Global Impressions of Improvement (PGI-I) Rate | 3.0 units on a scale STANDARD_DEVIATION 1.1 | 3.1 units on a scale STANDARD_DEVIATION 1.1 | 3.1 units on a scale STANDARD_DEVIATION 1.1 |
| Race/Ethnicity, Customized | 129 participants | 129 participants | 258 participants |
| Region of Enrollment Japan | 129 participants | 129 participants | 258 participants |
| Sex: Female, Male Female | 40 Participants | 22 Participants | 62 Participants |
| Sex: Female, Male Male | 89 Participants | 107 Participants | 196 Participants |
| Type of Diabetes Type I | 8 participants | 4 participants | 12 participants |
| Type of Diabetes Type II | 121 participants | 125 participants | 246 participants |
| Weight | 63.91 kilograms (kg) STANDARD_DEVIATION 12.13 | 64.98 kilograms (kg) STANDARD_DEVIATION 11.57 | 64.45 kilograms (kg) STANDARD_DEVIATION 11.84 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 126 / 129 | 121 / 129 |
| serious Total, serious adverse events | 11 / 129 | 22 / 129 |
Outcome results
Primary
Number of Participants Who Experienced an Adverse Event (AE)
See the Reported Adverse Events section for details.
Time frame: baseline through 1 year
Population: All participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duloxetine 40 mg | Number of Participants Who Experienced an Adverse Event (AE) | Serious Adverse Events | 11 participants |
| Duloxetine 40 mg | Number of Participants Who Experienced an Adverse Event (AE) | Adverse Events | 126 participants |
| Duloxetine 60 mg | Number of Participants Who Experienced an Adverse Event (AE) | Serious Adverse Events | 22 participants |
| Duloxetine 60 mg | Number of Participants Who Experienced an Adverse Event (AE) | Adverse Events | 121 participants |
Secondary
Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint
A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Time frame: 1 year
Population: Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 40 mg | Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint | 6.3 units on a scale | Standard Deviation 7.1 |
| Duloxetine 60 mg | Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint | 5.4 units on a scale | Standard Deviation 5.8 |
Secondary
Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint
Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: 1 year
Population: Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine 40 mg | Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint | Mood | 1.2 units on a scale | Standard Deviation 1.5 |
| Duloxetine 40 mg | Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint | Walking Ability | 1.4 units on a scale | Standard Deviation 1.7 |
| Duloxetine 40 mg | Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint | General Activities | 1.4 units on a scale | Standard Deviation 1.7 |
| Duloxetine 40 mg | Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint | Normal Work | 1.2 units on a scale | Standard Deviation 1.7 |
| Duloxetine 40 mg | Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint | Relation to People | 1.0 units on a scale | Standard Deviation 1.5 |
| Duloxetine 40 mg | Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint | Sleep | 1.2 units on a scale | Standard Deviation 1.5 |
| Duloxetine 40 mg | Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint | Enjoyment of Life | 1.2 units on a scale | Standard Deviation 1.6 |
| Duloxetine 40 mg | Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint | Average Score | 1.21 units on a scale | Standard Deviation 1.52 |
| Duloxetine 60 mg | Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint | Average Score | 1.28 units on a scale | Standard Deviation 1.48 |
| Duloxetine 60 mg | Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint | Mood | 1.3 units on a scale | Standard Deviation 1.6 |
| Duloxetine 60 mg | Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint | Relation to People | 1.1 units on a scale | Standard Deviation 1.4 |
| Duloxetine 60 mg | Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint | Walking Ability | 1.3 units on a scale | Standard Deviation 1.5 |
| Duloxetine 60 mg | Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint | Enjoyment of Life | 1.3 units on a scale | Standard Deviation 1.5 |
| Duloxetine 60 mg | Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint | General Activities | 1.4 units on a scale | Standard Deviation 1.6 |
| Duloxetine 60 mg | Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint | Sleep | 1.3 units on a scale | Standard Deviation 1.6 |
| Duloxetine 60 mg | Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint | Normal Work | 1.3 units on a scale | Standard Deviation 1.5 |
Secondary
Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint
A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.
Time frame: 1 year
Population: Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine 40 mg | Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint | Worst Pain | 2.4 units on a scale | Standard Deviation 1.9 |
| Duloxetine 40 mg | Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint | Least Pain | 1.3 units on a scale | Standard Deviation 1.5 |
| Duloxetine 40 mg | Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint | Average Pain | 1.8 units on a scale | Standard Deviation 1.5 |
| Duloxetine 40 mg | Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint | Pain Right Now | 1.7 units on a scale | Standard Deviation 1.6 |
| Duloxetine 60 mg | Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint | Pain Right Now | 1.7 units on a scale | Standard Deviation 1.6 |
| Duloxetine 60 mg | Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint | Worst Pain | 2.6 units on a scale | Standard Deviation 2 |
| Duloxetine 60 mg | Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint | Average Pain | 1.9 units on a scale | Standard Deviation 1.6 |
| Duloxetine 60 mg | Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint | Least Pain | 1.5 units on a scale | Standard Deviation 1.5 |
Secondary
Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Time frame: baseline, 1 year
Population: Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 40 mg | Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale | -0.9 units on a scale | Standard Deviation 1.1 |
| Duloxetine 60 mg | Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale | -1.0 units on a scale | Standard Deviation 1.1 |
Secondary
Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score
A 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Time frame: baseline, 1 year
Population: Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 40 mg | Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score | 0.2 units on a scale | Standard Deviation 4.4 |
| Duloxetine 60 mg | Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score | -0.7 units on a scale | Standard Deviation 3.7 |
Secondary
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores
Self-reported scale measures interference of pain on function in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes). Average interference = self-reported scale measures interference of pain on average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Average interference scores range from 0 (does not interfere) to 10 (completely interferes).
Time frame: baseline, 1 year
Population: Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine 40 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores | Normal Work | -1.0 units on a scale | Standard Deviation 1.8 |
| Duloxetine 40 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores | Walking Ability | -0.8 units on a scale | Standard Deviation 1.8 |
| Duloxetine 40 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores | Sleep | -1.0 units on a scale | Standard Deviation 2.1 |
| Duloxetine 40 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores | General Activities | -1.1 units on a scale | Standard Deviation 1.8 |
| Duloxetine 40 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores | Enjoyment of Life | -0.8 units on a scale | Standard Deviation 1.7 |
| Duloxetine 40 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores | Relation to People | -0.6 units on a scale | Standard Deviation 1.6 |
| Duloxetine 40 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores | Average Score | -0.93 units on a scale | Standard Deviation 1.57 |
| Duloxetine 40 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores | Mood | -1.1 units on a scale | Standard Deviation 1.8 |
| Duloxetine 60 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores | Average Score | -1.00 units on a scale | Standard Deviation 1.48 |
| Duloxetine 60 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores | Walking Ability | -1.0 units on a scale | Standard Deviation 1.6 |
| Duloxetine 60 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores | Relation to People | -0.7 units on a scale | Standard Deviation 1.6 |
| Duloxetine 60 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores | General Activities | -1.3 units on a scale | Standard Deviation 1.8 |
| Duloxetine 60 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores | Normal Work | -1.0 units on a scale | Standard Deviation 1.6 |
| Duloxetine 60 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores | Sleep | -1.1 units on a scale | Standard Deviation 2 |
| Duloxetine 60 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores | Enjoyment of Life | -0.8 units on a scale | Standard Deviation 1.5 |
| Duloxetine 60 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores | Mood | -1.0 units on a scale | Standard Deviation 1.7 |
Secondary
Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores
A self-reported scale that measures the severity of pain. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, and average pain in the past 24 hours, and the pain right now.
Time frame: baseline, 1 year
Population: Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duloxetine 40 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores | Average Pain | -2.1 units on a scale | Standard Deviation 1.7 |
| Duloxetine 40 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores | Worst Pain | -2.2 units on a scale | Standard Deviation 1.8 |
| Duloxetine 40 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores | Pain Right Now | -1.8 units on a scale | Standard Deviation 1.7 |
| Duloxetine 40 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores | Least Pain | -1.6 units on a scale | Standard Deviation 1.6 |
| Duloxetine 60 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores | Pain Right Now | -1.8 units on a scale | Standard Deviation 1.6 |
| Duloxetine 60 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores | Average Pain | -2.1 units on a scale | Standard Deviation 1.6 |
| Duloxetine 60 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores | Least Pain | -1.6 units on a scale | Standard Deviation 1.6 |
| Duloxetine 60 mg | Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores | Worst Pain | -2.3 units on a scale | Standard Deviation 1.9 |
Secondary
Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint.
A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Time frame: 1 year
Population: Intention to treat (ITT) population - participants were analyzed according to the groups to which they were originally assigned, whether or not they completed the protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine 40 mg | Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint. | 2.1 units on a scale | Standard Deviation 0.9 |
| Duloxetine 60 mg | Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint. | 2.1 units on a scale | Standard Deviation 1 |