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Study of Gralise to Treat Fibromyalgia Patients

NCT02052414 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2016-10-19

Study results available
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Summary

To determine Gralise in treating fibromyalgia pain:

* efficacy
* safety

Conditions

  • Fibromyalgia

Interventions

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.

Sponsors & Collaborators

  • Depomed

    collaborator INDUSTRY

  • The Center for Clinical Research, Winston-Salem, NC

    lead OTHER

Principal Investigators

  • James North, MD · Center for Clinical Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02052414 on ClinicalTrials.gov