Trial · NCT02052414
Study of Gralise to Treat Fibromyalgia Patients
NCT02052414, Not applicable, Completed, The Center for Clinical Research, Winston-Salem, NC; results first posted 2015-10-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Gralise to Treat Fibromyalgia Patients. Trials, record NCT02052414. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02052414
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Gralise to Treat Fibromyalgia Patients
- NCT number
- NCT02052414
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 34 participants, actual
- Lead sponsor
- The Center for Clinical Research, Winston-Salem, NC
- Conditions
- Fibromyalgia
- Interventions
- Gabapentin ER
- First posted
- 2014-02-03
- Last updated
- 2016-10-19
- Results first posted
- 2015-10-09
- Limitations and caveats
- small sample size, geographical bias, relatively short duration of treatment, open label, single arm study without a control group.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Numeric Pain Rating System (NPRS) | 15 weeks | 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). |
| Secondary | Medical Outcome Study (MOS) Sleep Questionnaires | 15 weeks | 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). |
| Secondary | Self Reported Side Effects. | 15 Weeks | Side / adverse effects were assessed at each follow up visits and resulted are as follows. |
| Secondary | Fibromyalgia Impact Questionnaire (FIQ) | 15 weeks. | 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. |
| Other | Patient Global Impression of Change (PGIC) | 15 Weeks. | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Numeric Pain Rating System (NPRS) | 15 weeks | All subjects had diagnosis of fibromyalgia and met the inclusion and exclusion criteria. | units on a scale | MEAN |
| SECONDARY | Medical Outcome Study (MOS) Sleep Questionnaires | 15 weeks | Hours | MEAN | |
| SECONDARY | Self Reported Side Effects. | 15 Weeks | 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. | participants | NUMBER |
| SECONDARY | Fibromyalgia Impact Questionnaire (FIQ) | 15 weeks. | FM patients who took study medication. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Patient Global Impression of Change (PGIC) | 15 Weeks. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Numeric Pain Rating System (NPRS) | Gralise (Gabapentin ER) | NPRS Baseline (Visit 1) | 7.29 | Standard Deviation 1.51 | units on a scale |
| Numeric Pain Rating System (NPRS) | Gralise (Gabapentin ER) | NPRS on Week 4 (Visit 2) | 4.72 | Standard Deviation 2.44 | units on a scale |
| Numeric Pain Rating System (NPRS) | Gralise (Gabapentin ER) | NPRS on week 8 (Visit 3) | 3.95 | Standard Deviation 2.18 | units on a scale |
| Numeric Pain Rating System (NPRS) | Gralise (Gabapentin ER) | NPRS on Week 12 (Visit 4) | 3.83 | Standard Deviation 2.05 | units on a scale |
| Numeric Pain Rating System (NPRS) | Gralise (Gabapentin ER) | NPRS on week 15 (Visit 5) | 6.94 | Standard Deviation 2.08 | units on a scale |
| Medical Outcome Study (MOS) Sleep Questionnaires | Gralise (Gabapentin ER) | Sleep Quantity Baseline | 5.86 | Standard Error 1.65 | Hours |
| Medical Outcome Study (MOS) Sleep Questionnaires | Gralise (Gabapentin ER) | Sleep Quantity week 4 | 7.17 | Standard Error 1.62 | Hours |
| Medical Outcome Study (MOS) Sleep Questionnaires | Gralise (Gabapentin ER) | Sleep quantity week 8 | 6.81 | Standard Error 1.81 | Hours |
| Medical Outcome Study (MOS) Sleep Questionnaires | Gralise (Gabapentin ER) | Sleep quantity week 12 | 7.04 | Standard Error 0.72 | Hours |
| Medical Outcome Study (MOS) Sleep Questionnaires | Gralise (Gabapentin ER) | Sleep quantity week 15 | 6.23 | Standard Error 1.71 | Hours |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gralise (Gabapentin ER) | 34 | |
| Overall Study | COMPLETED | Gralise (Gabapentin ER) | 17 | |
| Overall Study | NOT COMPLETED | Gralise (Gabapentin ER) | 17 |
Source ClinicalTrials.gov
Adverse events13
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Extremity swelling | Metabolism and nutrition disorders | Gralise (Gabapentin ER) | 2 | 31 | 2 |
| other | Weight Gain | Metabolism and nutrition disorders | Gralise (Gabapentin ER) | 2 | 31 | 2 |
| other | Drowsiness | Nervous system disorders | Gralise (Gabapentin ER) | 8 | 31 | 8 |
| other | Dizzines | Ear and labyrinth disorders | Gralise (Gabapentin ER) | 3 | 31 | 3 |
| other | irritability | Psychiatric disorders | Gralise (Gabapentin ER) | 3 | 31 | 3 |
| other | dry eyes | Eye disorders | Gralise (Gabapentin ER) | 2 | 31 | 2 |
| other | pain | Musculoskeletal and connective tissue disorders | Gralise (Gabapentin ER) | 1 | 31 | 1 |
| other | Mood changes | Psychiatric disorders | Gralise (Gabapentin ER) | 2 | 31 | 2 |
| other | Difficulty Concentrating | Nervous system disorders | Gralise (Gabapentin ER) | 2 | 31 | 2 |
| other | drymouth | Gastrointestinal disorders | Gralise (Gabapentin ER) | 1 | 31 | 1 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gralise (Gabapentin ER) | ||
| Total, other adverse events | Gralise (Gabapentin ER) | 10 | 31 |
| Total, serious adverse events | Gralise (Gabapentin ER) | 2 | 31 |
Source ClinicalTrials.gov
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02052414
GET https://conductscience.org/api/trials/v1/NCT02052414/results?page=2