Trial · NCT00797797
Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia
NCT00797797, Phase 3, Completed, Forest Laboratories; results first posted 2011-02-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia. Trials, record NCT00797797. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00797797
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia
- NCT number
- NCT00797797
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 364 participants, actual
- Lead sponsor
- Forest Laboratories
- Conditions
- Fibromyalgia
- Interventions
- No Treatment Added, Milnacipran Added
- First posted
- 2008-11-25
- Last updated
- 2011-02-16
- Results first posted
- 2011-02-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient Global Impression of Change (PGIC) Responder Rate at End of Study | End of Randomized treatment period (11 weeks) | The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as "very much improved" or "much improved" (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1. |
| Secondary | Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study | Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks) | The secondary efficacy measure was the change from Visit 2 (Week 0) in the 1-week pain recall at Visit 6 (Week 11) or End of Study, measured using a 100-mm VAS assessment of pain (0 indicating no pain and 100 indicating the worst possible pain). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patient Global Impression of Change (PGIC) Responder Rate at End of Study | End of Randomized treatment period (11 weeks) | All efficacy analyses are based on the Intent-to-Treat population, defined as all randomized patients who received at least one dose of randomized study drug and had at least one post-baseline PGIC assessment. | participants | NUMBER |
| SECONDARY | Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study | Baseline (0 weeks) and End of Randomized Treatment Period (11 weeks) | mm | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patient Global Impression of Change (PGIC) Responder Rate at End of Study | No Treatment Added | Responder | 36 | participants | |
| Patient Global Impression of Change (PGIC) Responder Rate at End of Study | Milnacipran Added | Responder | 83 | participants | |
| Patient Global Impression of Change (PGIC) Responder Rate at End of Study | No Treatment Added | Non-Responder | 137 | participants | |
| Patient Global Impression of Change (PGIC) Responder Rate at End of Study | Milnacipran Added | Non-Responder | 96 | participants | |
| Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study | No Treatment Added | -6.43 | Standard Error 1.93 | mm | |
| Change From Baseline in Visual Analog Scale (VAS) 1-week Pain Recall at End of Study | Milnacipran Added | -20.77 | Standard Error 1.92 | mm |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | No Treatment Added | 178 | |
| Overall Study | STARTED | Milnacipran Added | 184 | |
| Overall Study | COMPLETED | No Treatment Added | 123 | |
| Overall Study | COMPLETED | Milnacipran Added | 141 | |
| Overall Study | NOT COMPLETED | No Treatment Added | 55 | |
| Overall Study | NOT COMPLETED | Milnacipran Added | 43 |
Source ClinicalTrials.gov
Adverse events46
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 | Palpitations | Cardiac disorders | No Treatment Added | 0 | 178 | |
| other | Palpitations | Cardiac disorders | Milnacipran Added | 10 | 184 | |
| other | Nausea | Gastrointestinal disorders | No Treatment Added | 5 | 178 | |
| other | Nausea | Gastrointestinal disorders | Milnacipran Added | 23 | 184 | |
| other | Constipation | Gastrointestinal disorders | No Treatment Added | 1 | 178 | |
| other | Constipation | Gastrointestinal disorders | Milnacipran Added | 18 | 184 | |
| other | Dry Mouth | Gastrointestinal disorders | No Treatment Added | 0 | 178 | |
| other | Dry Mouth | Gastrointestinal disorders | Milnacipran Added | 10 | 184 | |
| other | Fatigue | General disorders | No Treatment Added | 4 | 178 | |
| other | Fatigue | General disorders | Milnacipran Added | 19 | 184 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | No Treatment Added | ||
| Total, all-cause mortality | Milnacipran Added | ||
| Total, other adverse events | No Treatment Added | 38 | 178 |
| Total, other adverse events | Milnacipran Added | 90 | 184 |
| Total, serious adverse events | No Treatment Added | 6 | 178 |
| Total, serious adverse events | Milnacipran Added | 5 | 184 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Milnacipran Added vs No Treatment Added: serious adverse events |
Source Trial comparisons
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/NCT00797797
GET https://conductscience.org/api/trials/v1/NCT00797797/events?page=2