Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057278
Status:
COMPLETED
Last Update Posted:
2007-12-19
First Post:
2003-03-28
Brief Title:
Gabapentin in Fibromyalgia Trial GIFT
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Study Overview
Official Title:
Gabapentin in Fibromyalgia Trial GIFT
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will assess the safety and effectiveness of the drug gabapentin in reducing pain associated with primary fibromyalgia
Detailed Description:
Fibromyalgia a chronic musculoskeletal pain disorder of unknown etiology is characterized by widespread musculoskeletal pain fatigue and multiple tender points the disease affects 3 to 6 million Americans A person is considered to have fibromyalgia if he or she has widespread pain in combination with tenderness in at least 11 of 18 specific tender point sites
Treatment of fibromyalgia requires a comprehensive approach and includes aerobic exercise heat and massage antidepressant medications and relaxation Gabapentin a medication used to treat seizures has been shown to work on pain transmission pathways and may relieve the pain associated with fibromyalgia This study will assess the efficacy of gabapentin in reducing pain severity in fibromyalgia as measured by the average pain item of the Brief Pain Inventory BPI score
Patients will be randomized to receive gabapentin or placebo The gabapentin dose will be titrated for persisting symptoms and as tolerated during the first 6 weeks of the study reaching final doses between 1800 mgday and 2400 mgday Patients will then continue on the final dose for the remaining 6 weeks of the study Following completion of the 12 week treatment phase patients will be tapered off of the medication over 1 week
The effectiveness of gabapentin will be assessed using the BPI The BPI is a self-administered questionnaire that measures the severity of pain and the interference of pain on function over the past 24 hours Other assessments will include the total Fibromyalgia Impact Questionnaire FIQ score six 11-point Likert-type scales in the FIQ that measure pain fatigue morning tiredness stiffness anxiety and depression the mean tender point pain threshold Clinical Global Impression of Severity CGI-Severity Patient Global Impression of Improvement PGI-Improvement the Short-form McGill Pain Questionnaire SF-MPQ the Medical Outcomes Study Short Form-36 SF-36 the Montgomery Asberg Depression Rating Scale MADRS and the Medical Outcomes Sleep Scale MOS-Sleep
Treatment of fibromyalgia requires a comprehensive approach and includes aerobic exercise heat and massage antidepressant medications and relaxation Gabapentin a medication used to treat seizures has been shown to work on pain transmission pathways and may relieve the pain associated with fibromyalgia This study will assess the efficacy of gabapentin in reducing pain severity in fibromyalgia as measured by the average pain item of the Brief Pain Inventory BPI score
Patients will be randomized to receive gabapentin or placebo The gabapentin dose will be titrated for persisting symptoms and as tolerated during the first 6 weeks of the study reaching final doses between 1800 mgday and 2400 mgday Patients will then continue on the final dose for the remaining 6 weeks of the study Following completion of the 12 week treatment phase patients will be tapered off of the medication over 1 week
The effectiveness of gabapentin will be assessed using the BPI The BPI is a self-administered questionnaire that measures the severity of pain and the interference of pain on function over the past 24 hours Other assessments will include the total Fibromyalgia Impact Questionnaire FIQ score six 11-point Likert-type scales in the FIQ that measure pain fatigue morning tiredness stiffness anxiety and depression the mean tender point pain threshold Clinical Global Impression of Severity CGI-Severity Patient Global Impression of Improvement PGI-Improvement the Short-form McGill Pain Questionnaire SF-MPQ the Medical Outcomes Study Short Form-36 SF-36 the Montgomery Asberg Depression Rating Scale MADRS and the Medical Outcomes Sleep Scale MOS-Sleep
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-089 | None | None | None |