Trial · NCT01623271
Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)
NCT01623271, Not applicable, Terminated, Massachusetts General Hospital; results first posted 2017-04-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise). Trials, record NCT01623271. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01623271
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)
- NCT number
- NCT01623271
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 5 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Complex Regional Pain Syndrome I (CRPS I)
- Interventions
- Gabapentin
- First posted
- 2012-06-19
- Last updated
- 2020-07-23
- Results first posted
- 2017-04-04
- Limitations and caveats
- Problems with recruitment and early termination of the study consequently resulted in uninterpretable data.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual Analog Scale (VAS) at Visit 3 | At visit 3 | Subjects rated their pain using the VAS at visit 3, which was the last day of their maintenance phase. After this visit, subjects begin to taper the gralise. The VAS is subject reported on a scale of 0-10 with 0 being no pain and 10 being the worst pain they can imagine. Results reported are an average of the 3 subjects who completed visit 3. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Visual Analog Scale (VAS) at Visit 3 | At visit 3 | Only 3 subjects completed visit 3. The other 2 subjects dropped out due to expected side effects. | units on the VAS | MEAN |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Visual Analog Scale (VAS) at Visit 3 | CRPS I Pain Subjects | 3.67 | Standard Deviation 1.15 | units on the VAS |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CRPS I Pain Subjects | 5 | |
| Overall Study | COMPLETED | CRPS I Pain Subjects | 3 | |
| Overall Study | NOT COMPLETED | CRPS I Pain Subjects | 2 |
Source ClinicalTrials.gov
Adverse events1
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 | Expected Side Effects of Gralise | General disorders | CRPS I Pain Subjects | 2 | 5 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CRPS I Pain Subjects | ||
| Total, other adverse events | CRPS I Pain Subjects | 2 | 5 |
| Total, serious adverse events | CRPS I Pain Subjects | 0 | 5 |
Source ClinicalTrials.gov
Papers5
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/NCT01623271
GET https://conductscience.org/api/trials/v1/NCT01623271/registered