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| Name | Class |
|---|---|
| Depomed | INDUSTRY |
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To determine Gralise in treating fibromyalgia pain:
Subject must carry a diagnosis of fibromyalgia based on American College of Rheumatology (ACR) criteria for fibromyalgia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gralise (Gabapentin ER) | Experimental | All patients will be treated with Gralise. Patients who are on pregabalin or gabapentin (lyrica or neurontin) will need to wash off the medication before starting Gralise. Patients who are ready to take Gralise will start with starter pack, and will gradually titrate the dose up to 1800mg per day. After that, patient will take 1800mg per day out of the bottle. Patient will be seen in clinic at 4weeks intervals for first 4 visits, and then there will be end of the study visit on week 15. On visit 4, week 12 of treatment, patients will be taught to taper off the study medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin ER | Drug | Patient who are on gralise will report efficacy by rating his or her pain rating on a digital pain scale (11 points) from 0 to 10 on each scheduled clinical visits, which will be compared to their pain level at baseline. In addition, patients will also record the doses and any adverse effects that might arise during the trial in a diary provided by the study. All information will be recorded in a paper diary that will be followed by coordinator during each follow up visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating System (NPRS) | Fibromyalgia pain experienced by study subjects will be captured using NPRS at baseline visit, at each follow visits that are scheduled to occur every 4 weeks over 12 weeks of treatment period, and at the end of treatment visit that will occur 3 weeks after treatment period (12 weeks treatment period + 3 weeks = 15 weeks). Any difference in NPRS scores between baseline and any subsequent visits will indicate the magnitude of pain relief as reflected in digital scale of 0-10 (0=no pain, 10=worst pain imaginable). | 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Medical Outcome Study (MOS) Sleep Questionnaires | Medical Outcomes Study (MOS) sleep questionnaires to assess how Fibromyalgia impacts patients' sleep in various areas. Specifically, Data reported below measured number of hours subjects spent per night sleeping. MOS sleep questionnaires were assessed at each follow up visits. (visits 1, 2, 3, 4, and 5). | 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change (PGIC) | Patient Global impression of Change (PGIC) is an outcome commonly used measure of the efficacy of treatments. PGIC is a 7 point scale that requires the subjects to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James North, MD | Center for Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2306288 | Background | Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203. | |
| 8860800 |
| Label | URL |
|---|---|
| Drug manufacturer's website | View source |
Not provided
No individual participants data will be shared with anyone who is not a member of the study staff, and all records containing individual data and their protected health information will remain confidential in accordance with the HIPAA rules.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gralise (Gabapentin ER) | An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial. All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day. Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit. Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gralise (Gabapentin ER) | This is an open label trial to evaluate the efficacy of Gralise against fibromyalgia pain. If subject is taking gabapentinoids at the time of enrollment, subjects will be required to wash off the medication; otherwise they can start the starter pack for Gralise, and will eventually up titrated to treatment dose of 1800mg with evening meals per day. Subjects will be followed every 4 weeks for total of 12 weeks. At the end of 12 weeks, subjects will be wash off the Gralise over 2 weeks, and will have a final end of treatment visit at week 15. Subjects will be asked to rate their pain on numeric pain rating system (NPRS) as primary outcome measure. Subjects will be asked to assess Fibromyalgia Impact Questionnaire (FIQ), Medical Outcome Study (MOS) Sleep questionnaire, and Patient Global Impression of Change (PGIC) as secondary outcome measures. At each follow up visits, occurrence of adverse events, and changes to concomitant medications were evaluated and recorded. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Numeric Pain Rating System (NPRS) | Fibromyalgia pain experienced by study subjects will be captured using NPRS at baseline visit, at each follow visits that are scheduled to occur every 4 weeks over 12 weeks of treatment period, and at the end of treatment visit that will occur 3 weeks after treatment period (12 weeks treatment period + 3 weeks = 15 weeks). Any difference in NPRS scores between baseline and any subsequent visits will indicate the magnitude of pain relief as reflected in digital scale of 0-10 (0=no pain, 10=worst pain imaginable). | All subjects had diagnosis of fibromyalgia and met the inclusion and exclusion criteria. | Posted | Mean | Standard Deviation | units on a scale | 15 weeks |
|
Adverse events data were collected at baseline (visit 1), week 4 (visit 2), week 8 (visit 3), week 12 (visit 4), and week 15 (visit 5). If subject required unscheduled visit, AE were collected as part of the visit procedure.
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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 | Gralise (Gabapentin ER) | An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial. All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day. Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit. Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small bowel adhesion | Gastrointestinal disorders | Side effects profile | Systematic Assessment | Subject had a laparoscopic bariatric surgery few years ago, and as a consequence subject suffered a bowel adhesion and subsequent small bowel obstruction. Subject underwent lysis of adhesion, and recovered without sequelae. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extremity swelling | Metabolism and nutrition disorders | Side effects profile | Systematic Assessment | bilateral upper extremity swelling. |
small sample size, geographical bias, relatively short duration of treatment, open label, single arm study without a control group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James M. North MD | The Center for Clinical Research | 3367656181 | jnorth1@ccrpain.com |
Not provided
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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|
|
| Self Reported Side Effects. | Side / adverse effects were assessed at each follow up visits and resulted are as follows. | 15 Weeks |
| Fibromyalgia Impact Questionnaire (FIQ) | The Fibromyalgia Impact Questionnaire (FIQ) is an instrument designed to quantitate the overall impact of fibromyalgia over many dimensions (e.g. function, pain level, fatigue, sleep disturbance, psychological distress etc.). It is scored from 0 to 100 with the latter number being the worst case. The average score for patients seen in tertiary care settings is about 50. The FIQ is widely used to assess change in fibromyalgia status. | 15 weeks. |
| 15 Weeks. |
| Hudson JI, Pope HG Jr. The relationship between fibromyalgia and major depressive disorder. Rheum Dis Clin North Am. 1996 May;22(2):285-303. doi: 10.1016/s0889-857x(05)70273-8. |
| 7818567 | Background | Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum. 1995 Jan;38(1):19-28. doi: 10.1002/art.1780380104. |
| 10749947 | Background | Arnold LM, Keck PE Jr, Welge JA. Antidepressant treatment of fibromyalgia. A meta-analysis and review. Psychosomatics. 2000 Mar-Apr;41(2):104-13. doi: 10.1176/appi.psy.41.2.104. |
| 16298061 | Background | Arnold LM, Rosen A, Pritchett YL, D'Souza DN, Goldstein DJ, Iyengar S, Wernicke JF. A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder. Pain. 2005 Dec 15;119(1-3):5-15. doi: 10.1016/j.pain.2005.06.031. Epub 2005 Nov 17. |
| 9365080 | Background | Pillemer SR, Bradley LA, Crofford LJ, Moldofsky H, Chrousos GP. The neuroscience and endocrinology of fibromyalgia. Arthritis Rheum. 1997 Nov;40(11):1928-39. doi: 10.1002/art.1780401103. No abstract available. |
| 9303250 | Background | Lautenbacher S, Rollman GB. Possible deficiencies of pain modulation in fibromyalgia. Clin J Pain. 1997 Sep;13(3):189-96. doi: 10.1097/00002508-199709000-00003. |
| 10221469 | Background | Bennett RM. Emerging concepts in the neurobiology of chronic pain: evidence of abnormal sensory processing in fibromyalgia. Mayo Clin Proc. 1999 Apr;74(4):385-98. doi: 10.4065/74.4.385. |
| 12126581 | Background | Staud R. Evidence of involvement of central neural mechanisms in generating fibromyalgia pain. Curr Rheumatol Rep. 2002 Aug;4(4):299-305. doi: 10.1007/s11926-002-0038-5. |
| 9481803 | Background | Baranauskas G, Nistri A. Sensitization of pain pathways in the spinal cord: cellular mechanisms. Prog Neurobiol. 1998 Feb;54(3):349-65. doi: 10.1016/s0301-0082(97)00067-1. |
| 17393438 | Background | Arnold LM, Goldenberg DL, Stanford SB, Lalonde JK, Sandhu HS, Keck PE Jr, Welge JA, Bishop F, Stanford KE, Hess EV, Hudson JI. Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial. Arthritis Rheum. 2007 Apr;56(4):1336-44. doi: 10.1002/art.22457. |
| 9714500 | Background | Gidal BE, DeCerce J, Bockbrader HN, Gonzalez J, Kruger S, Pitterle ME, Rutecki P, Ramsay RE. Gabapentin bioavailability: effect of dose and frequency of administration in adult patients with epilepsy. Epilepsy Res. 1998 Jul;31(2):91-9. doi: 10.1016/s0920-1211(98)00020-5. |
| website for center for clinical research | View source |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Age of Fibromyalgia Diagnosis | Mean | Full Range | years |
|
| Number of active medications | Mean | Full Range | medications |
|
| Number of past medications | Mean | Full Range | medications |
|
| Number of co-morbid conditions | Mean | Full Range | co-morbid conditions present |
|
| Gabapentinoid (Gabapentin/ pregabalin) Naive | Of all the subjects participated in this trial, 8 subjects were Gabapentinoid naïve. | Number | participants |
|
|
|
| Secondary | Medical Outcome Study (MOS) Sleep Questionnaires | Medical Outcomes Study (MOS) sleep questionnaires to assess how Fibromyalgia impacts patients' sleep in various areas. Specifically, Data reported below measured number of hours subjects spent per night sleeping. MOS sleep questionnaires were assessed at each follow up visits. (visits 1, 2, 3, 4, and 5). | Posted | Mean | Standard Error | Hours | 15 weeks |
|
|
|
| Secondary | Self Reported Side Effects. | Side / adverse effects were assessed at each follow up visits and resulted are as follows. | Subject who experienced pain, acute delirium, symptoms related to adhesions due to prior surgical procedures, extremity swelling, and possible drug interactions discontinued medications. Other reported side effects dissipated after subjects reached therapeutic dose of 1800mg of study medication taken at bedtime. | Posted | Number | participants | 15 Weeks |
|
|
|
| Secondary | Fibromyalgia Impact Questionnaire (FIQ) | The Fibromyalgia Impact Questionnaire (FIQ) is an instrument designed to quantitate the overall impact of fibromyalgia over many dimensions (e.g. function, pain level, fatigue, sleep disturbance, psychological distress etc.). It is scored from 0 to 100 with the latter number being the worst case. The average score for patients seen in tertiary care settings is about 50. The FIQ is widely used to assess change in fibromyalgia status. | FM patients who took study medication. | Posted | Mean | Standard Deviation | units on a scale | 15 weeks. |
|
|
|
| Other Pre-specified | Patient Global Impression of Change (PGIC) | Patient Global impression of Change (PGIC) is an outcome commonly used measure of the efficacy of treatments. PGIC is a 7 point scale that requires the subjects to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. | Posted | Mean | Standard Deviation | units on a scale | 15 Weeks. |
|
|
|
| 2 |
| 31 |
| 10 |
| 31 |
|
| Acute Delirium | Nervous system disorders | Side effects profile | Systematic Assessment | Subject exhibited early signs and symptoms of alzheimers symptoms. Subject was seen at ED on Friday, and admitted to neurology care for observation and work up over the weekend. \ |
|
|
| Weight Gain | Metabolism and nutrition disorders | Side effects profile | Systematic Assessment | Subjects gained weight after starting on study medication |
|
| Drowsiness | Nervous system disorders | Side effects profile | Systematic Assessment | Drowsy |
|
| Dizzines | Ear and labyrinth disorders | Side effects profile | Systematic Assessment | Dizzy |
|
| irritability | Psychiatric disorders | Side effects profile | Systematic Assessment |
|
| dry eyes | Eye disorders | Side effects profile | Systematic Assessment |
|
| pain | Musculoskeletal and connective tissue disorders | Side effects profile | Systematic Assessment |
|
| Mood changes | Psychiatric disorders | Side effects profile | Systematic Assessment |
|
| Difficulty Concentrating | Nervous system disorders | Side effects profile | Systematic Assessment |
|
| drymouth | Gastrointestinal disorders | Side effects profile | Systematic Assessment |
|
| drug interaction | Metabolism and nutrition disorders | Side effects profile | Systematic Assessment |
|
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| D009422 |
| Nervous System Diseases |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| Title | Measurements |
|---|---|
|
| Sleep quantity week 12 |
|
| Sleep quantity week 15 |
|
| Title | Measurements |
|---|---|
|
| Dizzy |
|
| Irritability |
|
| Dry Eyes |
|
| Pain |
|
| Mood Changes |
|
| Difficulty Concentrating |
|
| Dry Mouth |
|
| Suspected Drug interaction |
|
| Acute Delerium |
|
| Adhesion |
|
| None |
|
| Title | Measurements |
|---|---|
|
| FIQ Week 12 |
|
| FIQ Week 15 |
|
| Title | Measurements |
|---|---|
|
| PGIC After 15 weeks |
|