NCT02052414

Study of Gralise to Treat Fibromyalgia Patients

Open Labeled, Non-randomized, Study of Efficacy and Safety of Gralise in Fibromyalgia Patients.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: The Center for Clinical Research, Winston-Salem, NC · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

To determine Gralise in treating fibromyalgia pain: * efficacy * safety

Detailed description

Subject must carry a diagnosis of fibromyalgia based on American College of Rheumatology (ACR) criteria for fibromyalgia * Patient may be gaba-analogue (Pregabalin, trade name: lyrica, or Gabapentin, trade name: Neurontin) naïve, or had been on other gaba analogue before, and discontinued for lack of efficacy. * Patient who had allergic reaction or serious adverse reactions will not be included in this study. * Patient will start with starter pack of Gralise and will reach therapeutic dose of 1800 mg per day by end of 2 weeks. * Drug is to be taken with meal, once a day in the evening; once patient has reached the therapeutic dose of 1800 mg, patient will come in for visit, at which point the PI will evaluate the patient and may increase or decrease the dosage, but patient may not increase or decrease the dose of medication at his /her discretion. * During study, patient will have total of 5 visits, 4 of which will be for duration patient will be on Gralise, and the last visit will be for tapering off the medication. * During study, patient is asked keep a paper diary on which patient will record the numeric pain scale from Fibromyalgia, time the medication was taken, dose of medication, and any side effects.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Gabapentin ER	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.

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2014-02-03
• Last updated: 2016-10-19
• Results posted: 2015-10-09

Locations

1 site across 1 country: United States