Trial · NCT01652001
Drug-induced Xerostomia. Evaluation of Malic Acid 1%, Salivary Mucins and Buffering Capacity
NCT01652001, Phase 2, Phase 3, Completed, Universidad de Granada; results first posted 2016-04-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Drug-induced Xerostomia. Evaluation of Malic Acid 1%, Salivary Mucins and Buffering Capacity. Trials, record NCT01652001. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01652001
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Drug-induced Xerostomia. Evaluation of Malic Acid 1%, Salivary Mucins and Buffering Capacity
- NCT number
- NCT01652001
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 185 participants, actual
- Lead sponsor
- Universidad de Granada
- Conditions
- Xerostomia, Depression, Hypertension
- Interventions
- Malic Acid, Placebo
- First posted
- 2012-07-27
- Last updated
- 2016-04-05
- Results first posted
- 2016-04-05
- Limitations and caveats
- Some of the participants forgot the appointment because the time between phases were of two weeks
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dry Mouth Questionnaire (DMQ) | 2 weeks | Dry Mouth Questionnaire (DMQ) was used in order to obtain subjective information about the severity of xerostomia before and after treatment with malic acid/placebo. Every participant answered an initial questionnaire (DMQ 1) about the symptoms related to oral dryness, before receiving a spray (1% malic acid or placebo). After two weeks of applications, patients had to answer DMQ 1 again as well as an additional questionnaire (DMQ 2) about the efficacy of the sprays. Increased DMQ scores indicate improvement of xerostomia. DMQ 1 was used to assess the initial severity of oral dryness and in particular its impact on oral function: problems when chewing, swallowing, speaking and general impact on daily life. DMQ 1 used a 0-to-4 rating scale where 0 = "very dry" and 4 = "not dry at all." After two weeks of treatment, DMQ 1 was repeated and it was included DMQ 2. At the end values of DMQ 1 and DMQ 2 were summed |
| Secondary | Sialometries | 2 weeks | Unstimulated and stimulated salivary flow rates were assessed in all patients. The unstimulated salivary flow rate was obtained by the spit method every 30 seconds for 15 minutes. Saliva was collected in 20 mL plastic containers, which were pre-weighted. Stimulated whole saliva was obtained by chewing a 1 g piece of paraffin wax for six minutes. Saliva collected during the first minute was discarded, and then collected into the container every 30 seconds. |
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 | Dry Mouth Questionnaire (DMQ) | 2 weeks | units on a scale | MEAN | |
| SECONDARY | Sialometries | 2 weeks | mL/min | 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 |
|---|---|---|---|---|---|
| Dry Mouth Questionnaire (DMQ) | Malic Acid 1% | 3.4 | Standard Deviation 0.6 | units on a scale | |
| Dry Mouth Questionnaire (DMQ) | Control | 1.4 | Standard Deviation 0.5 | units on a scale | |
| Sialometries | Malic Acid 1% | Unstimulated Salivary Flow rate | 0.17 | Standard Deviation 0.07 | mL/min |
| Sialometries | Control | Unstimulated Salivary Flow rate | 0.16 | Standard Deviation 0.09 | mL/min |
| Sialometries | Malic Acid 1% | Stimulated Salivary Flow Rate | 0.93 | Standard Deviation 0.27 | mL/min |
| Sialometries | Control | Stimulated Salivary Flow Rate | 0.75 | Standard Deviation 0.35 | mL/min |
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 | Malic Acid 1% | 100 | |
| Overall Study | STARTED | Control | 85 | |
| Overall Study | COMPLETED | Malic Acid 1% | 91 | |
| Overall Study | COMPLETED | Control | 79 | |
| Overall Study | NOT COMPLETED | Malic Acid 1% | 9 | |
| Overall Study | NOT COMPLETED | Control | 6 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Malic Acid 1% | ||
| Total, all-cause mortality | Control | ||
| Total, other adverse events | Malic Acid 1% | 0 | 100 |
| Total, other adverse events | Control | 0 | 85 |
| Total, serious adverse events | Malic Acid 1% | 0 | 100 |
| Total, serious adverse events | Control | 0 | 85 |
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 |
|---|
| Malic Acid 1% vs Control: 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/NCT01652001
GET https://conductscience.org/api/trials/v1/NCT01652001/registered