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| ID | Type | Description | Link |
|---|---|---|---|
| F1J-JE-HMHA | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Shionogi | INDUSTRY |
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The main purpose of this study is to evaluate the effectiveness and safety of the study drug known as duloxetine in participants with diabetic peripheral neuropathic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine | Experimental | 20 milligrams (mg) duloxetine orally once a day (QD) for one week and then 40 mg duloxetine orally QD for 3 weeks. Duloxetine dosage may be increased up to 60 mg QD at week 4 or week 8. Placebo will be given with duloxetine for blinding. Dosage will be tapered down during the final week of the study. |
|
| Pregabalin | Active Comparator | 150 mg pregabalin orally twice a day (BID) for 1 week and then 300 mg pregabalin orally BID for 3 weeks. Pregabalin dosage may be increased up to 450 mg BID at week 4 or 8, and increased up to 600 mg BID at week 8. Placebo will be given with pregabalin for blinding. Dosage will be tapered down during the final week of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | Administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 12 Weeks in the Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale (NRS) | 11-point NRS measures the severity of pain over the previous 24 hours. Participants were asked to provide 24-hour average pain scores in the daily Participant diary and among these, the weekly mean of the 24-hour average pain score was calculated. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Mixed Model Repeated Measures (MMRM) model with baseline value, Duration of diabetic peripheral neuropathic pain (DPNP), treatment, week, treatment-by-week interaction as fixed effects was used to produce Least Square Mean (LS Mean). | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Improvement (PGI-I) at 12 Weeks | PGI-I assessments was completed by the participant. The participant records how he/she perceives the degree of improvement (or worsening) at the time of assessment since taking treatment. The score ranges from 1 (very much better) to 7 (very much worse). MMRM model with duration of DPNP, treatment, visit, treatment-by-visit interaction as fixed effects was used to produce LS Mean. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30271191 | Derived | Enomoto H, Yasuda H, Nishiyori A, Fujikoshi S, Furukawa M, Ishida M, Takahashi M, Tsuji T, Yoshikawa A, Alev L. Duloxetine in patients with diabetic peripheral neuropathic pain in Japan: a randomized, doubleblind, noninferiority comparative study with pregabalin. J Pain Res. 2018 Sep 13;11:1857-1868. doi: 10.2147/JPR.S170646. eCollection 2018. |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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12 week Treatment period, followed by 1 week Tapering period, followed by 1 week follow-up period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Participants received flexible doses of 150 to 600 mg pregabalin orally twice a day (BID) along with Duloxetine placebo during treatment period. Participants who received higher doses of Pregabalin in treatment period received gradually the lower doses of Pregabalin along with Duloxetine placebo during tapering period. |
| FG001 | Duloxetine | Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo during treatment period. Participants who received higher doses of Duloxetine in treatment period received gradually the lower doses of Duloxetine along with Pregabalin placebo during tapering period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
|
| ||||||||||||||||||||||||
| Tapering Period |
|
All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine placebo during treatment period. Participants who received higher doses of Pregabalin in treatment period received gradually the lower doses of Pregabalin along with Duloxetine placebo during tapering period. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to 12 Weeks in the Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale (NRS) | 11-point NRS measures the severity of pain over the previous 24 hours. Participants were asked to provide 24-hour average pain scores in the daily Participant diary and among these, the weekly mean of the 24-hour average pain score was calculated. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Mixed Model Repeated Measures (MMRM) model with baseline value, Duration of diabetic peripheral neuropathic pain (DPNP), treatment, week, treatment-by-week interaction as fixed effects was used to produce Least Square Mean (LS Mean). | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for NRS. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
|
Up to 14 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin | Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 2, 2017 | Mar 25, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol | May 29, 2014 | Mar 25, 2018 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol Amendment (a) | Sep 30, 2014 | Mar 25, 2018 | Prot_002.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol Amendment (b) | Apr 17, 2015 | Mar 25, 2018 | Prot_003.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol Amendment (c) | Aug 5, 2016 | Mar 25, 2018 | Prot_004.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol Amendment (d) | Sep 14, 2016 | Mar 25, 2018 | Prot_005.pdf |
| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pregabalin | Drug | Administered orally |
|
| Placebo | Drug | Administered orally |
|
| Week 12 |
| Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF) | Brief Pain Inventory Severity and Interference Scores: BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (pain as bad as you can imagine) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. MMRM model with baseline, duration of DPNP, treatment, visit, treatment-by-visit interaction as fixed effects was used to produce LS mean. | Baseline, Week 12 |
| Change From Baseline to 12 Weeks on the Neuropathic Pain Symptom Inventory (NPSI) | NPSI questionnaire is a 12-item self-administered questionnaire that will be completed by the participant. It assesses 5 different dimensions of neuropathic pain on a scale of 0 (no symptom) to 10 (worst imaginable symptom): burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesias/dysesthesias. The NPSI includes 12 items: 10 descriptors of the different symptoms and 2 items for assessing the duration of spontaneous ongoing and paroxysmal pain. A total score can be calculated as the sum of the scores of the 10 descriptors with scale range: 0 (no pain) -100 (worst pain imaginable). Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) with baseline, treatment, and duration of DPNP as fixed effects was used to produce LS mean. | Baseline, Week 12 |
| Clinical Global Impression of Improvement (CGI-I) at 12 Weeks | CGI-I measures clinician's perception of participant improvement at the time of assessment (compared with the start of treatment) with scores ranging from 1 (very much better) to 7 (very much worse). MMRM model with duration of DPNP, treatment, visit and treatment-by-visit interaction as fixed effects was used to produce LS Mean. | Week 12 |
| Change From Baseline to 12 Weeks on the EuroQol 5 Dimension (EQ-5D) | The EQ-5D is a self-reported, 5-item scale used to assess the patient's health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale.These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm (range of the Index score is -0.111 - 1).A higher score indicates better health state. ANCOVA model with LOCF with baseline value, treatment and duration of DPNP as fixed effects was used to produce LS mean. | Baseline, Week 12 |
| Change From Baseline to 12 Weeks on the Beck Depression Inventory-II (BDI-II) Total Score | Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe. MMRM model with baseline value, duration of DPNP, treatment, visit and treatment-by-visit interaction as fixed effects was used to produce LS mean. | Baseline, Week 12 |
| Change From Baseline to 12 Weeks in the Weekly Mean of Night Pain Scores on the 11-Point NRS | Night pain severity scores were recorded on an 11-point NRS in the daily patient diary, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).The weekly mean of the night pain score was calculated based on the daily pain score. MMRM model with baseline value, treatment, week, duration of DPNP and treatment-by-week interaction as fixed effects was used to produce LS mean. | Baseline, Week 12 |
| Change From Baseline to 12 Weeks in the Weekly Mean of the 24-Hour Worst Pain Scores on the 11-Point NRS | 24-hour worst pain severity scores were recorded on an 11-point NRS in the daily patient diary, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).The weekly mean of the worst pain score was calculated based on the daily score. MMRM model with baseline value, duration of DPNP, treatment, week, treatment-by-week interaction as fixed effects was used to produce LS mean. | Baseline, Week 12 |
| Number of Participants With a 30% and 50% Reduction in the Weekly Mean of the 24-Hour Average Pain Score on the 11-Point NRS at 12 Weeks | 11-point NRS measures the severity of pain over the previous 24 hours. Patients were asked to provide 24-hour average pain scores in the daily patient diary. scores range from 0 (no pain) to 10 (pain as bad as you can imagine) and among these, the weekly mean of the 24-hour average pain score was calculated based on daily score. | Week 12 |
| Entry Criteria not met |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| NOT COMPLETED |
|
| Duloxetine |
Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo during treatment period. Participants who received higher doses of Duloxetine in treatment period received gradually the lower doses of Duloxetine along with Pregabalin placebo during tapering period. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Numeric Rating Scale (NRS) | 24-hour average pain, night pain & 24-hour worst pain severity scores were recorded on an 11-point NRS, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).Weekly mean was calculated based on daily score and used for the analysis. | Mean | Standard Deviation | units on a scale |
|
| Brief Pain Inventory - Short Form (BPI-SF) | BPI Severity (BPI-S) & BPI Interference Scores (BPI-I) are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (as bad as you can imagine) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. | Mean | Standard Deviation | units on a scale |
|
| Beck Depression Inventory-II (BDI-II) | Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe. | Mean | Standard Deviation | units on a scale |
|
| Neuropathic Pain Symptom Inventory (NPSI) | NPSI questionnaire is a 12-item self-administered questionnaire that will be completed by the patient. It assesses 5 different dimensions of neuropathic pain: burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesias/dysesthesias. The NPSI includes 12 items: 10 descriptors of the different symptoms and 2 items for assessing the duration of spontaneous ongoing and paroxysmal pain. A total intensity score can be calculated as the sum of the scores of the 10 descriptors. (range: 0 (no pain) -100 (worst imaginable pain)). | Mean | Standard Deviation | units on a scale |
|
| EuroQol 5 Dimension (EQ-5D) | The EQ-5D is a self-reported, 5-item scale used to assess the patient's health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale.These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm.Range of the Index score is -0.111 - 1(higher score indicates better health state). | Mean | Standard Deviation | units on a scale |
|
Participants received flexible doses of 150 to 600 mg Pregabalin orally twice a day (BID) along with Duloxetine Placebo.
| OG001 | Duloxetine | Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo. |
|
|
|
| Secondary | Patient Global Impression of Improvement (PGI-I) at 12 Weeks | PGI-I assessments was completed by the participant. The participant records how he/she perceives the degree of improvement (or worsening) at the time of assessment since taking treatment. The score ranges from 1 (very much better) to 7 (very much worse). MMRM model with duration of DPNP, treatment, visit, treatment-by-visit interaction as fixed effects was used to produce LS Mean. | All randomized participants who received at least one dose of study drug and had at least one post baseline observation. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 12 |
|
|
|
|
| Secondary | Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF) | Brief Pain Inventory Severity and Interference Scores: BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (pain as bad as you can imagine) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. MMRM model with baseline, duration of DPNP, treatment, visit, treatment-by-visit interaction as fixed effects was used to produce LS mean. | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for BPI-SF. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
|
|
|
|
| Secondary | Change From Baseline to 12 Weeks on the Neuropathic Pain Symptom Inventory (NPSI) | NPSI questionnaire is a 12-item self-administered questionnaire that will be completed by the participant. It assesses 5 different dimensions of neuropathic pain on a scale of 0 (no symptom) to 10 (worst imaginable symptom): burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesias/dysesthesias. The NPSI includes 12 items: 10 descriptors of the different symptoms and 2 items for assessing the duration of spontaneous ongoing and paroxysmal pain. A total score can be calculated as the sum of the scores of the 10 descriptors with scale range: 0 (no pain) -100 (worst pain imaginable). Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) with baseline, treatment, and duration of DPNP as fixed effects was used to produce LS mean. | All randomized participants who received at least one dose of study drug & had baseline & at least one post-baseline observation for NPSI. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
|
|
|
|
| Secondary | Clinical Global Impression of Improvement (CGI-I) at 12 Weeks | CGI-I measures clinician's perception of participant improvement at the time of assessment (compared with the start of treatment) with scores ranging from 1 (very much better) to 7 (very much worse). MMRM model with duration of DPNP, treatment, visit and treatment-by-visit interaction as fixed effects was used to produce LS Mean. | All randomized participants who received at least one dose of study drug and had at least one post baseline observation for CGI-I | Posted | Least Squares Mean | Standard Error | units on a scale | Week 12 |
|
|
|
|
| Secondary | Change From Baseline to 12 Weeks on the EuroQol 5 Dimension (EQ-5D) | The EQ-5D is a self-reported, 5-item scale used to assess the patient's health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale.These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm (range of the Index score is -0.111 - 1).A higher score indicates better health state. ANCOVA model with LOCF with baseline value, treatment and duration of DPNP as fixed effects was used to produce LS mean. | All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline observation for EQ-5D. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
|
|
|
|
| Secondary | Change From Baseline to 12 Weeks on the Beck Depression Inventory-II (BDI-II) Total Score | Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe. MMRM model with baseline value, duration of DPNP, treatment, visit and treatment-by-visit interaction as fixed effects was used to produce LS mean. | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for BDI-II. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
|
|
|
|
| Secondary | Change From Baseline to 12 Weeks in the Weekly Mean of Night Pain Scores on the 11-Point NRS | Night pain severity scores were recorded on an 11-point NRS in the daily patient diary, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).The weekly mean of the night pain score was calculated based on the daily pain score. MMRM model with baseline value, treatment, week, duration of DPNP and treatment-by-week interaction as fixed effects was used to produce LS mean. | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for night pain NRS. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
|
|
|
|
| Secondary | Change From Baseline to 12 Weeks in the Weekly Mean of the 24-Hour Worst Pain Scores on the 11-Point NRS | 24-hour worst pain severity scores were recorded on an 11-point NRS in the daily patient diary, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).The weekly mean of the worst pain score was calculated based on the daily score. MMRM model with baseline value, duration of DPNP, treatment, week, treatment-by-week interaction as fixed effects was used to produce LS mean. | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for worst pain score NRS. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 12 |
|
|
|
|
| Secondary | Number of Participants With a 30% and 50% Reduction in the Weekly Mean of the 24-Hour Average Pain Score on the 11-Point NRS at 12 Weeks | 11-point NRS measures the severity of pain over the previous 24 hours. Patients were asked to provide 24-hour average pain scores in the daily patient diary. scores range from 0 (no pain) to 10 (pain as bad as you can imagine) and among these, the weekly mean of the 24-hour average pain score was calculated based on daily score. | All randomized participants who received at least one dose of study drug & had baseline & at least one post-baseline observation for average pain score NRS . | Posted | Count of Participants | Participants | Week 12 |
|
|
|
|
| 0 |
| 151 |
| 6 |
| 151 |
| 91 |
| 151 |
| EG001 | Duloxetine | Participants received flexible doses of 20 to 60 mg Duloxetine orally once a day (QD) along with Pregabalin placebo. | 0 | 152 | 1 | 152 | 86 | 152 |
| Myocardial infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Macular oedema | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Open angle glaucoma | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Retinopathy | Eye disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Chronic gastritis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Diabetic gastroenteropathy | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastroduodenal ulcer | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nodule | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Xerosis | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Myringitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Periodontitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Pyoderma | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Skin bacterial infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Tinea manuum | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Animal bite | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Heat illness | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Skin wound | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Glycosylated haemoglobin increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 20.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Diabetic neuropathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Visual field defect | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Depressive symptom | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| Diabetic nephropathy | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| Hypertonic bladder | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| Urinary hesitation | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
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| Prostatomegaly | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
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| Nasal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
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| Lymphoedema | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
Not provided
| D006571 |
| Heterocyclic Compounds |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| Least Pain |
|
|
| Average Pain |
|
|
| Pain Right Now |
|
|
| General Activity |
|
|
| Mood |
|
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| Walking Ability |
|
|
| Normal Work |
|
|
| Relations with Other People |
|
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| Sleep |
|
|
| Enjoyment of Life |
|
|
| Average Interference |
|
|
| .436 |
| Mean Difference (Final Values) |
| -0.1 |
| 2-Sided |
| 95 |
| -0.5 |
| 0.2 |
| Other |
| Average Pain | Mixed Models Analysis | .534 | Mean Difference (Final Values) | 0.1 | 2-Sided | 95 | -0.2 | 0.5 | Other |
| Pain Right Now | Mixed Models Analysis | .948 | Mean Difference (Final Values) | 0.0 | 2-Sided | 95 | -0.4 | 0.4 | Other |
| General Activity | Mixed Models Analysis | .225 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -0.6 | 0.1 | Other |
| Mood | Mixed Models Analysis | .276 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -0.6 | 0.2 | Other |
| Walking Ability | Mixed Models Analysis | .507 | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -0.4 | 0.2 | Other |
| Normal Work | Mixed Models Analysis | .216 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -0.5 | 0.1 | Other |
| Relations with other people | Mixed Models Analysis | .233 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -0.4 | 0.1 | Other |
| Sleep | Mixed Models Analysis | .857 | Mean Difference (Final Values) | -0.0 | 2-Sided | 95 | -0.3 | 0.3 | Other |
| Enjoyment of life | Mixed Models Analysis | .133 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -0.5 | 0.1 | Other |
| Average Interference Score | Mixed Models Analysis | .246 | Mean Difference (Final Values) | -0.16 | 2-Sided | 95 | -0.44 | 0.11 | Other |
| Pressing Pain |
|
| Paroxysmal Pain |
|
| Evoked Pain |
|
| Paresthesia/Dysesthesia |
|
| .355 |
| Mean Difference (Final Values) |
| -0.2 |
| 2-Sided |
| 95 |
| -0.6 |
| 0.2 |
| Other |
| Pressing Pain | ANCOVA | .731 | Mean Difference (Final Values) | 0.1 | 2-Sided | 95 | -0.3 | 0.4 | Other |
| Paroxysmal Pain | ANCOVA | .721 | Mean Difference (Final Values) | 0.1 | 2-Sided | 95 | -0.3 | 0.4 | Other |
| Evoked Pain | ANCOVA | .345 | Mean Difference (Final Values) | -0.2 | 2-Sided | 95 | -0.5 | 0.2 | Other |
| Paresthesia/Dysesthesia | ANCOVA | .557 | Mean Difference (Final Values) | -0.1 | 2-Sided | 95 | -0.5 | 0.3 | Other |
| .907 |
| Other |