Trial · NCT00747747
Sinuclean's Treatment Of Sinusitis' Symptoms
NCT00747747, Phase 4, Completed, Galsor S.r.l.; results first posted 2012-03-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sinuclean's Treatment Of Sinusitis' Symptoms. Trials, record NCT00747747. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00747747
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sinuclean's Treatment Of Sinusitis' Symptoms
- NCT number
- NCT00747747
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 49 participants, actual
- Lead sponsor
- Galsor S.r.l.
- Conditions
- Sinusitis
- Interventions
- Saline solution, Sinuclean DM Spray
- First posted
- 2008-09-05
- Last updated
- 2012-03-14
- Other registries' IDs
- eudract:2007-003739-22
- Results first posted
- 2012-03-14
- Limitations and caveats
- Clinical diagnosis could not be confirmed before treatment start due to logistics problems to make cranial MRI in due time.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) | After one week | Mucus detection in paranasal sinuses by clinical assessment(Outcome measure Percentage of patients) |
| Primary | Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) | After two weeks | Mucus detection in paranasal sinuses by clinical assessment(Outcome Measure Percentage of patients) |
| Secondary | FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject | After one week | Patient's daily diary retrospective ranked assessment of symptoms (0,1,2,3 with 0 = no symptoms; frequencies of patients with rank "0" were compared as outcome measure between groups |
| Secondary | FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject | After two weeks | Patient's daily diary retrospective ranked assessment of symptoms (0,1,2,3 with 0 = no symptoms; frequencies of patients with rank "0" were compared as outcome measure between groups. |
| Secondary | Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients) | After one week | Clinical assessment of healing of the sinusitis episode(Outcome Measure Percentage of patients healed). Healing was assessed clinically by the physician as recovery of the condition prior to the diagnosis of the episode of sinusitis, without need of medical treatment. |
| Secondary | Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients) | After two weeks | Clinical assessment of healing of the sinusitis episode (Outcome Measure Percentage of patients healed. Healing was assessed clinically by the physician as recovery of the condition prior to the diagnosis of the episode of sinusitis, without need of medical treatment. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) | After one week | The patients were eligible according to inclusion and exclusion criteria and were compliant with the study requirements. | percentage of patients | NUMBER |
| SECONDARY | FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject | After one week | Eligibility per in/ex criteria and compliance with study requirements and diary completion requirements | percentage of patients | NUMBER |
| SECONDARY | FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject | After two weeks | percentage of patients | NUMBER | |
| PRIMARY | Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) | After two weeks | percentage of patients | NUMBER | |
| SECONDARY | Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients) | After one week | Eligibility according to in/ex criteria and compliance with study requirements | percentage of patients | NUMBER |
| SECONDARY | Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients) | After two weeks | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) | Control | 71 | percentage of patients | ||
| Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) | Saline Treated. | 57 | percentage of patients | ||
| Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) | Sinuclean Treated. | 33 | percentage of patients | ||
| FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject | Control | 57 | percentage of patients | ||
| FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject | Saline Treated. | 43 | percentage of patients | ||
| FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject | Sinuclean Treated. | 52 | percentage of patients | ||
| FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject | Control | 79 | percentage of patients | ||
| FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject | Saline Treated. | 93 | percentage of patients | ||
| FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject | Sinuclean Treated. | 81 | percentage of patients | ||
| Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) | Control | 29 | percentage of patients |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control | 14 | |
| Overall Study | STARTED | Saline Treated. | 14 | |
| Overall Study | STARTED | Sinuclean Treated. | 21 | |
| Overall Study | COMPLETED | Control | 14 | |
| Overall Study | COMPLETED | Saline Treated. | 14 | |
| Overall Study | COMPLETED | Sinuclean Treated. | 21 | |
| Overall Study | NOT COMPLETED | Control | 0 | |
| Overall Study | NOT COMPLETED | Saline Treated. | 0 | |
| Overall Study | NOT COMPLETED | Sinuclean Treated. | 0 |
Source ClinicalTrials.gov
Adverse events3
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 | Flu syndrome | Respiratory, thoracic and mediastinal disorders | Control | 0 | 14 | 0 |
| other | Flu syndrome | Respiratory, thoracic and mediastinal disorders | Saline Treated. | 1 | 14 | 1 |
| other | Flu syndrome | Respiratory, thoracic and mediastinal disorders | Sinuclean Treated. | 0 | 21 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control | ||
| Total, all-cause mortality | Saline Treated. | ||
| Total, all-cause mortality | Sinuclean Treated. | ||
| Total, other adverse events | Control | 0 | 14 |
| Total, other adverse events | Saline Treated. | 1 | 14 |
| Total, other adverse events | Sinuclean Treated. | 0 | 21 |
| Total, serious adverse events | Control | 0 | 14 |
| Total, serious adverse events | Saline Treated. | 0 | 14 |
| Total, serious adverse events | Sinuclean Treated. | 0 | 21 |
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/NCT00747747
GET https://conductscience.org/api/trials/v1/NCT00747747/registered