CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
Gabapentin ERdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02052414
NCT02052414N/ACompleted
CompareCT.gov

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

The Center for Clinical Research, Winston-Salem, NC·interventional·Posted Feb 3, 2014·Updated Oct 19, 2016

In Brief

A clinical study evaluating Gabapentin ER for Fibromyalgia. Completed, enrolled 34 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
CollaboratorsDepomed

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 3, 2014
Enrollment StartJul 1, 2012
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.4 years ago

Interventions

Gabapentin ERdrug

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.