Trial · NCT00976963
Single Dose Monurol for Treatment of Acute Cystitis
NCT00976963, Not applicable, Completed, University of Washington; results first posted 2023-06-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Single Dose Monurol for Treatment of Acute Cystitis. Trials, record NCT00976963. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00976963
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Single Dose Monurol for Treatment of Acute Cystitis
- NCT number
- NCT00976963
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 300 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Urinary Tract Infection
- Interventions
- TMP/SMX, Fosfomycin
- First posted
- 2009-09-15
- Last updated
- 2023-06-05
- Results first posted
- 2023-06-05
- Limitations and caveats
- The clinicians and participants were not blinded as to the assigned intervention.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Were Cured | 28-30 days post therapy | Cure as defined by no further treatment for subsequent or unresolved symptoms, by modified ITT approach. |
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 | Number of Participants Who Were Cured | 28-30 days post therapy | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Were Cured | TMP/SMX | 120 | Participants | ||
| Number of Participants Who Were Cured | Fosfomycin | 130 | Participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TMP/SMX | 150 | |
| Overall Study | STARTED | Fosfomycin | 150 | |
| Overall Study | Treated With Assigned Intervention | TMP/SMX | 146 | |
| Overall Study | Treated With Assigned Intervention | Fosfomycin | 150 | |
| Overall Study | COMPLETED | TMP/SMX | 146 | |
| Overall Study | COMPLETED | Fosfomycin | 150 | |
| Overall Study | NOT COMPLETED | TMP/SMX | 4 | |
| Overall Study | NOT COMPLETED | Fosfomycin | 0 |
Source ClinicalTrials.gov
Adverse events12
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 | Nausea | Gastrointestinal disorders | TMP/SMX | 22 | 143 | |
| other | Nausea | Gastrointestinal disorders | Fosfomycin | 3 | 145 | |
| other | Loose stools | Gastrointestinal disorders | TMP/SMX | 7 | 143 | |
| other | Loose stools | Gastrointestinal disorders | Fosfomycin | 28 | 145 | |
| other | Abdominal discomfort | Gastrointestinal disorders | TMP/SMX | 10 | 143 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Fosfomycin | 12 | 145 | |
| other | Headache | General disorders | TMP/SMX | 11 | 143 | |
| other | Headache | General disorders | Fosfomycin | 3 | 145 | |
| other | Dizziness | General disorders | TMP/SMX | 7 | 143 | |
| other | Dizziness | General disorders | Fosfomycin | 3 | 145 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TMP/SMX | 0 | 150 |
| Total, all-cause mortality | Fosfomycin | 0 | 150 |
| Total, other adverse events | TMP/SMX | 46 | 143 |
| Total, other adverse events | Fosfomycin | 43 | 145 |
| Total, serious adverse events | TMP/SMX | 0 | 150 |
| Total, serious adverse events | Fosfomycin | 0 | 150 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TMP/SMX vs Fosfomycin: Number of Participants Who Were Cured | Trial comparisons |
| TMP/SMX vs Fosfomycin: deaths from any cause | Trial comparisons |
| TMP/SMX vs Fosfomycin: serious adverse events | 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/NCT00976963
GET https://conductscience.org/api/trials/v1/NCT00976963/registered