Trial · NCT01327339
REQUIP RLS Post Marketing Surveillance
NCT01327339, Completed, GlaxoSmithKline; results first posted 2011-04-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. REQUIP RLS Post Marketing Surveillance. Trials, record NCT01327339. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01327339
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- REQUIP RLS Post Marketing Surveillance
- NCT number
- NCT01327339
- Status
- Completed
- Enrollment
- 755 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Restless Legs Syndrome
- Interventions
- Ropinirole
- First posted
- 2011-04-01
- Last updated
- 2017-09-12
- Results first posted
- 2011-04-01
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Any Adverse Event | one month | An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Secondary | Number of Participants With Any Serious Adverse Event | one month | A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening , requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record. |
| Secondary | Number of Participants With the Indicated Unexpected Adverse Events | one month | An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Adverse Event | one month | Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had completed all safety assessments. | participants | NUMBER |
| SECONDARY | Number of Participants With Any Serious Adverse Event | one month | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Unexpected Adverse Events | one month | ITT Population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Any Adverse Event | Requip 0.25 mg, 1 mg, 2 mg | 44 | participants | ||
| Number of Participants With Any Serious Adverse Event | Requip 0.25 mg, 1 mg, 2 mg | 3 | participants | ||
| Number of Participants With the Indicated Unexpected Adverse Events | Requip 0.25 mg, 1 mg, 2 mg | Weight Decrease | 2 | participants | |
| Number of Participants With the Indicated Unexpected Adverse Events | Requip 0.25 mg, 1 mg, 2 mg | Thirsty | 1 | participants | |
| Number of Participants With the Indicated Unexpected Adverse Events | Requip 0.25 mg, 1 mg, 2 mg | Eye Pain | 1 | participants | |
| Number of Participants With the Indicated Unexpected Adverse Events | Requip 0.25 mg, 1 mg, 2 mg | Saliva Increased | 1 | participants | |
| Number of Participants With the Indicated Unexpected Adverse Events | Requip 0.25 mg, 1 mg, 2 mg | Melena | 1 | participants | |
| Number of Participants With the Indicated Unexpected Adverse Events | Requip 0.25 mg, 1 mg, 2 mg | Amnesia | 1 | participants | |
| Number of Participants With the Indicated Unexpected Adverse Events | Requip 0.25 mg, 1 mg, 2 mg | Appendicitis | 1 | participants |
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 | Requip 0.25 mg, 1 mg, 2 mg | 755 | |
| Overall Study | COMPLETED | Requip 0.25 mg, 1 mg, 2 mg | 747 | |
| Overall Study | NOT COMPLETED | Requip 0.25 mg, 1 mg, 2 mg | 8 |
Source ClinicalTrials.gov
Adverse events24
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 | Requip 0.25 mg, 1 mg, 2 mg | 13 | 747 | |
| other | Nausea | Gastrointestinal disorders | Requip 0.25 mg, 1 mg, 2 mg | 11 | 747 | |
| other | Dizziness | Nervous system disorders | Requip 0.25 mg, 1 mg, 2 mg | 7 | 747 | |
| other | Vomiting | Gastrointestinal disorders | Requip 0.25 mg, 1 mg, 2 mg | 6 | 747 | |
| other | Chest Pain | General disorders | Requip 0.25 mg, 1 mg, 2 mg | 3 | 747 | |
| other | Somnolence | Psychiatric disorders | Requip 0.25 mg, 1 mg, 2 mg | 3 | 747 | |
| other | Dysesthesia | Nervous system disorders | Requip 0.25 mg, 1 mg, 2 mg | 3 | 747 | |
| other | Headache | General disorders | Requip 0.25 mg, 1 mg, 2 mg | 3 | 747 | |
| other | Weight Decrease | Metabolism and nutrition disorders | Requip 0.25 mg, 1 mg, 2 mg | 2 | 747 | |
| other | Abdominal Pain | Gastrointestinal disorders | Requip 0.25 mg, 1 mg, 2 mg | 1 | 747 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Requip 0.25 mg, 1 mg, 2 mg | ||
| Total, other adverse events | Requip 0.25 mg, 1 mg, 2 mg | 44 | 747 |
| Total, serious adverse events | Requip 0.25 mg, 1 mg, 2 mg | 3 | 747 |
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 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/NCT01327339
GET https://conductscience.org/api/trials/v1/NCT01327339/events?page=2