Trial · NCT00689052
Pramipexole ER vs. Placebo in Fibromyalgia
NCT00689052, Phase 2, Terminated, Boehringer Ingelheim; results first posted 2009-11-25
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Pramipexole ER vs. Placebo in Fibromyalgia. Trials, record NCT00689052. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00689052
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pramipexole ER vs. Placebo in Fibromyalgia
- NCT number
- NCT00689052
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 61 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Fibromyalgia
- Interventions
- pramipexole ER, placebo
- First posted
- 2008-06-03
- Last updated
- 2014-06-09
- Results first posted
- 2009-11-25
- Limitations and caveats
- Early termination leading to no number of subjects analysed for any outcome measure
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change in the Weekly Mean of the 24-hour Average Pain Score From a Daily Diary as Measured by the 11-point Likert Pain Scale | Baseline and Week 29 | The 11-point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from 0 (no pain) to 10 (worst possible pain) |
| Secondary | The Proportion of Patients "Very Much Improved" or "Much Improved" on the Patient's Global Impression of Improvement (PGI-I) 7-point Scale | Week 29 (at the end of the maintenance phase) | PGI-I is a self-reported scale completed by the patient that measures the degree of improvement at the time of assessment. The score ranges from 1 = very much improved to 7 = very much worse |
| Secondary | The Short Form 36 (SF-36) Health Survey, Physical Functioning Subscale (Change From Baseline). | Baseline and Week 29 | The SF-36 Health Survey is a self-administered 36-item instrument completed by the patient . SF 36 has subscales as follows: i) physical functioning (PF), ii) role limitations due to physical problems (RP), iii) bodily pain (BP), iv) general health perceptions (GH), v) vitality (VT), vi) social function (SF), vii) role limitations due to emotional problems (RE), viii) mental health (MH),ix)physical component summary (PCS)and x)mental component summary(MCS). Among the subscales, Physical functioning was key secondary endpoint while other were additional secondary endpoints. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The number of items per domain varies from 2 to 1 |
| Secondary | The Proportion of Patients With at Least a 30% or at Least a 50% Improvement Relative to Baseline in Pain (Assessed on the 11-point Likert Pain Scale | Baseline and Week 29 | 11-Point Likert Pain Scale is a numerical rating scale completed by the patient that measures the intensity of pain. The intensity scores range from: 0 = no pain to 10 = worst possible pain . |
| Secondary | Fibromyalgia Impact Questionnaire (FIQ) Total Score (Change From Baseline) | Baseline and Week 29 | FIQ is a self-reported scale completed by the patient that measures patient status, progress, and outcomes over the past week. The FIQ is composed of a total of 20 items; the first 11 items measure physical functioning, and each item is rated on a four-point Likert scale. Items 12 and 13 measure the number of days the patient felt well and the number of days the patient felt unable to work due to their fibromyalgia symptoms. Items 14 through 20 are numerical, 11-point Likert scales (marked in 10-point increments) on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The total score ranges from 0 to 80. A higher score indicates a more negative impact |
| Secondary | Hospital Anxiety and Depression Scale (HADS) (Change From Baseline). | Baseline and Week 29 | The Hospital Anxiety and Depression Scale (HADS) measures the severity of anxiety and depression. The severity score ranges from: 0 = least severe to 3 = most severe. The total score ranges from 0 to 21; the higher the score, the more severe the anxious/depressive symptoms |
| Secondary | The Short Form 36 (SF-36) Health Survey (Change From Baseline) (Excluding the Physical Functioning Subscale(PF)). | Baseline and Week 29 | The SF-36 Health Survey is a self-administered 36-item instrument completed by the patient . SF 36 has subscales as follows: i) physical functioning (PF), ii) role limitations due to physical problems (RP), iii) bodily pain (BP), iv) general health perceptions (GH), v) vitality (VT), vi) social function (SF), vii) role limitations due to emotional problems (RE), viii) mental health (MH),ix)physical component summary (PCS)and x)mental component summary(MCS). Among the subscales, Physical functioning was key secondary endpoint while other were additional secondary endpoints. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The number of items per domain varies from 2 to 1 |
| Secondary | Euroqol- 5 Dimensions (EQ-5D) Survey (Change From Baseline) | Baseline and Week 29 | The Euroqol- 5 Dimension (EQ-5D) Health Survey is a generic, multidimensional, health related, quality-of-life instrument that contains two parts-a health status profile and a visual analog scale (VAS) to rate global health-related quality of life. The profile contains five items corresponding to five health domains- mobility, self-care, usual activities, pain/discomfort, and mood. A single score is generated for each health state. Data from the EQ-5D can be converted into 243 unique health states. For each health state, there exists a corresponding valuation that allows the patient's health to be represented as an index, which is a value between -0.594 and 1; the higher the score, the better the quality of life. |
| Secondary | Multidimensional Assessment of Fatigue (MAF) Index (Change From Baseline) | Baseline and Week 29 | The Multidimensional Assessment of Fatigue (MAF) Index is a 16-item, self-reporting instrument designed to collect data on four dimensions of fatigue- severity, distress, degree of interference in activities of daily living, and timing . |
| Secondary | Medical Outcomes Study (MOS) Sleep Scale (Change From Baseline) | Baseline and Week 29 | The Medical Outcomes Study (MOS) sleep scale is a 12-item (MOS1 to MOS12) self reporting sleep measure. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Change in the Weekly Mean of the 24-hour Average Pain Score From a Daily Diary as Measured by the 11-point Likert Pain Scale | Baseline and Week 29 | FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS)) | ||
| SECONDARY | The Proportion of Patients Very Much Improved or Much Improved on the Patient's Global Impression of Improvement (PGI-I) 7-point Scale | Week 29 (at the end of the maintenance phase) | FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS)) | ||
| SECONDARY | The Short Form 36 (SF-36) Health Survey, Physical Functioning Subscale (Change From Baseline). | Baseline and Week 29 | FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS)) | ||
| SECONDARY | The Proportion of Patients With at Least a 30% or at Least a 50% Improvement Relative to Baseline in Pain (Assessed on the 11-point Likert Pain Scale | Baseline and Week 29 | FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS)) | ||
| SECONDARY | Fibromyalgia Impact Questionnaire (FIQ) Total Score (Change From Baseline) | Baseline and Week 29 | FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS)) | ||
| SECONDARY | Hospital Anxiety and Depression Scale (HADS) (Change From Baseline). | Baseline and Week 29 | FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS)) | ||
| SECONDARY | The Short Form 36 (SF-36) Health Survey (Change From Baseline) (Excluding the Physical Functioning Subscale(PF)). | Baseline and Week 29 | FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS)) | ||
| SECONDARY | Euroqol- 5 Dimensions (EQ-5D) Survey (Change From Baseline) | Baseline and Week 29 | FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS)) | ||
| SECONDARY | Multidimensional Assessment of Fatigue (MAF) Index (Change From Baseline) | Baseline and Week 29 | FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS)) | ||
| SECONDARY | Medical Outcomes Study (MOS) Sleep Scale (Change From Baseline) | Baseline and Week 29 | FAS (All randomized and treated patients with a baseline and at least one post-baseline will be included in the Full Analysis Set (FAS)) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 31 | |
| Overall Study | STARTED | Pramipexole | 30 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | COMPLETED | Pramipexole | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 31 | |
| Overall Study | NOT COMPLETED | Pramipexole | 30 |
Source ClinicalTrials.gov
Adverse events28
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 | insomnia | Psychiatric disorders | Placebo | 3 | 31 | |
| other | insomnia | Psychiatric disorders | Pramipexole | 5 | 30 | |
| other | sleep attacks | Psychiatric disorders | Placebo | 0 | 31 | |
| other | sleep attacks | Psychiatric disorders | Pramipexole | 3 | 30 | |
| other | somnolence | Nervous system disorders | Placebo | 1 | 31 | |
| other | somnolence | Nervous system disorders | Pramipexole | 5 | 30 | |
| other | dizziness | Nervous system disorders | Placebo | 1 | 31 | |
| other | dizziness | Nervous system disorders | Pramipexole | 2 | 30 | |
| other | headache | Nervous system disorders | Placebo | 2 | 31 | |
| other | headache | Nervous system disorders | Pramipexole | 2 | 30 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Pramipexole | ||
| Total, other adverse events | Placebo | 10 | 31 |
| Total, other adverse events | Pramipexole | 18 | 30 |
| Total, serious adverse events | Placebo | 1 | 31 |
| Total, serious adverse events | Pramipexole | 0 | 30 |
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 |
|---|
| Pramipexole vs Placebo: 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/NCT00689052
GET https://conductscience.org/api/trials/v1/NCT00689052/events?page=2