Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The patients are asked to take part in this study because you have chronic pain as a result of knee osteoarthritis. This study is done to investigate the pain relieving effects of the study drug Savella (milnacipran HCl) for people who experience chronic osteoarthritis pain. The purpose of this research is to look at how the study drug can be used to benefit people who experience osteoarthritis knee pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug is already approved by the Food and Drug Administration for people with fibromyalgia but it has not yet been approved for people with knee osteoarthritis.
If you are in this study, you will be placed in one of two study groups: one group will receive the study drug and one will receive a placebo. You will be assigned a study group by chance using a process similar to the flip of a coin.
At the first visit (week one) we will review and sign the informed consent, obtain your medical health history, and conduct a brief physical exam. You will also complete several questionnaires about your pain. You will be assessed for your eligibility to participate in this study. If you are eligible, we will conduct some physical and sensory tests and collect a blood sample. The physical tests include a stair climb, 6-minute treadmill test and a 1-minute sit to stand test. The sensory tests allow us to understand your perception of various stimuli such as vibration, light touch, pinprick, heat, cold, hot pain, and cold pain. At the end of the first visit you will be given an electronic diary to record your pain throughout the study. We will also ask you to wear a device in a T-shirt, similar to an accelerometer, that will be used to record your sleep quality and physical activity for 2 days.
At the second (week two) and third visits (week nine) you will be asked to complete the same questionnaires, physical and sensory tests as during the first visit. You will also have to wear the t-shirt with the device for 2 days after each visit.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar Pill | Placebo Comparator | BID placebo |
|
| Milnacipran | Experimental | Uptitration from 10mg to 50mg BID Milnacipran |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milnacipran | Drug | Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used. |
| Measure | Description | Time Frame |
|---|---|---|
| McGill Pain Questionnaire - Short Form | The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain). | Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. |
| PamSys Actigraph Data | We used a body worn sensor (PAMSys™, Biosensics, LLC, MA)(25-27) embedded in a comfortable t-shirt at the sternal level. Participants wore the PAMSys after the visit for 48 hours. The device provides values related to subjects spontaneous physical activity including percentage of time standing and walking. These variables provide different indexes of participants' level of activity and activity organization, and were reported by subjects with KOA pain as relevant. | 48 hours after visit 3 |
| Pain Anxiety Symptoms Scale (PASS) | Anxiety scores were collected at least two data points. The Pain Anxiety Symptoms Scale (PASS) is a scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety. | Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. |
| Pain Disability Index (PDI) | The PDI is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability. | Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. |
| Center for Epidemiological Studies Depression Scale CESD-10 (CES-D 10) | The CES-D 10 is a 10-item questionnaire that has been validated for the assessment of depressive symptomatology. The Depression Scale is a scale with a sum score from 0 - 30, where 0 = no Depression and 30 = the most Depression. |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Diary Entries With Pain, Fatigue and Functioning Scores Three Times a Day | Averages of daily diary outcomes were taken over the first and last week of the trial (week 1 and week 11) to compare pre and post treatment. diary was filled out 3 times a day and asked subjects to rate pain at rest, pain when walking, and fatigue on a scale 0-10 (0=none, and 10=the worst) | electronic diary entries with pain, fatigue and functioning scores were completed three times a day during week 1 and week 11 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Norman Harden, MD | Center for Pain Studies, Rehabilitation Institute of Chicago | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36269595 | Derived | Leaney AA, Lyttle JR, Segan J, Urquhart DM, Cicuttini FM, Chou L, Wluka AE. Antidepressants for hip and knee osteoarthritis. Cochrane Database Syst Rev. 2022 Oct 21;10(10):CD012157. doi: 10.1002/14651858.CD012157.pub2. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sugar Pill | Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication. |
| FG001 | Milnacipran | Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sugar Pill | Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication. |
| BG001 | Milnacipran | Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used. |
| 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 | McGill Pain Questionnaire - Short Form | The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain). | Posted | Mean | Standard Deviation | units on a pain scale | Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Milnacipran | Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. R. Norman Harden | Rehabilitation Institute of Chicago Center for Pain Studies | 312.238.5654 | centerforpainstudies@ric.org |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D007592 | Joint Diseases |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078764 | Milnacipran |
| D013607 | Tablets |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Placebo | Drug | Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication. |
|
|
| Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. |
| Pain Visual Analogue Scale | Pain Visual Analogue Scale from 0-100 (0= no pain, and 100= most pain). | Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sugar Pill | Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication. |
|
|
| Secondary | Daily Diary Entries With Pain, Fatigue and Functioning Scores Three Times a Day | Averages of daily diary outcomes were taken over the first and last week of the trial (week 1 and week 11) to compare pre and post treatment. diary was filled out 3 times a day and asked subjects to rate pain at rest, pain when walking, and fatigue on a scale 0-10 (0=none, and 10=the worst) | Posted | Mean | Standard Deviation | units on a 0-10 NRS scale | electronic diary entries with pain, fatigue and functioning scores were completed three times a day during week 1 and week 11 |
|
|
|
| Primary | PamSys Actigraph Data | We used a body worn sensor (PAMSys™, Biosensics, LLC, MA)(25-27) embedded in a comfortable t-shirt at the sternal level. Participants wore the PAMSys after the visit for 48 hours. The device provides values related to subjects spontaneous physical activity including percentage of time standing and walking. These variables provide different indexes of participants' level of activity and activity organization, and were reported by subjects with KOA pain as relevant. | Posted | Mean | Standard Error | percentage of activity (over 48 hours) | 48 hours after visit 3 |
|
|
|
| Primary | Pain Anxiety Symptoms Scale (PASS) | Anxiety scores were collected at least two data points. The Pain Anxiety Symptoms Scale (PASS) is a scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety. | Posted | Mean | Standard Deviation | units on an anxiety scale | Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. |
|
|
|
| Primary | Pain Disability Index (PDI) | The PDI is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability. | Posted | Mean | Standard Deviation | units on a disability scale | Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. |
|
|
|
| Primary | Center for Epidemiological Studies Depression Scale CESD-10 (CES-D 10) | The CES-D 10 is a 10-item questionnaire that has been validated for the assessment of depressive symptomatology. The Depression Scale is a scale with a sum score from 0 - 30, where 0 = no Depression and 30 = the most Depression. | Posted | Mean | Standard Deviation | units on the depression scale | Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. |
|
|
|
| Primary | Pain Visual Analogue Scale | Pain Visual Analogue Scale from 0-100 (0= no pain, and 100= most pain). | Posted | Mean | Standard Deviation | units on a 100mm pain scale | Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. |
|
|
|
| 0 |
| 26 |
| 9 |
| 26 |
| EG001 | Sugar Pill | Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication. | 0 | 12 | 0 | 12 |
| Fatigue | General disorders | Systematic Assessment |
|
| Trouble Sleeping | General disorders | Systematic Assessment |
|
| Constipation | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Transient tachycardia | Cardiac disorders | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D002241 | Carbohydrates |
| Ave Pain walking reported on Diary over Week 1 |
|
| Ave Pain walking reported on Diary over Week 11 |
|
| Ave Fatigue reported on Diary over Week 1 |
|
| Ave Fatigue reported on Diary over Week 11 |
|