Trial · NCT01673620
A Study to Evaluate the Safety of Combination Montelukast/Loratadine in Mexican Participants With Allergic Rhinitis (MK-0476A-484)
NCT01673620, Phase 3, Completed, Organon and Co; results first posted 2014-11-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Safety of Combination Montelukast/Loratadine in Mexican Participants With Allergic Rhinitis (MK-0476A-484). Trials, record NCT01673620. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01673620
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety of Combination Montelukast/Loratadine in Mexican Participants With Allergic Rhinitis (MK-0476A-484)
- NCT number
- NCT01673620
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 69 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Allergic Rhinitis
- Interventions
- Montelukast 10 mg/loratadine 10 mg, Placebo
- First posted
- 2012-08-28
- Last updated
- 2024-09-04
- Results first posted
- 2014-11-14
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing at Least One Adverse Event (AE) | Up to 4 weeks | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment. |
| Primary | Number of Participants Discontinuing Study Treatment Due to AEs | Up to 2 weeks | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment. |
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 | Number of Participants Experiencing at Least One Adverse Event (AE) | Up to 4 weeks | The All-Patients-as-Treated (APaT) population consisted of all randomized participants who received at least one dose of study drug. | participants | NUMBER |
| PRIMARY | Number of Participants Discontinuing Study Treatment Due to AEs | Up to 2 weeks | The APaT population consisted of all randomized participants who received at least one dose of study drug. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experiencing at Least One Adverse Event (AE) | Montelukast 10 mg/Loratadine 10 mg | 6 | participants | ||
| Number of Participants Experiencing at Least One Adverse Event (AE) | Placebo | 2 | participants | ||
| Number of Participants Discontinuing Study Treatment Due to AEs | Montelukast 10 mg/Loratadine 10 mg | 1 | participants | ||
| Number of Participants Discontinuing Study Treatment Due to AEs | Placebo | 0 | participants |
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 | Montelukast 10 mg/Loratadine 10 mg | 47 | |
| Overall Study | STARTED | Placebo | 22 | |
| Overall Study | COMPLETED | Montelukast 10 mg/Loratadine 10 mg | 46 | |
| Overall Study | COMPLETED | Placebo | 22 | |
| Overall Study | NOT COMPLETED | Montelukast 10 mg/Loratadine 10 mg | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Dry mouth | Gastrointestinal disorders | Montelukast 10 mg/Loratadine 10 mg | 3 | 47 | 3 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 0 | 22 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Montelukast 10 mg/Loratadine 10 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Montelukast 10 mg/Loratadine 10 mg | 3 | 47 |
| Total, other adverse events | Placebo | 0 | 22 |
| Total, serious adverse events | Montelukast 10 mg/Loratadine 10 mg | 0 | 47 |
| Total, serious adverse events | Placebo | 0 | 22 |
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 |
|---|---|
| Montelukast 10 mg/Loratadine 10 mg vs Placebo: Number of Participants Discontinuing Study Treatment Due to AEs | Trial comparisons |
| Montelukast 10 mg/Loratadine 10 mg vs Placebo: Number of Participants Experiencing at Least One Adverse Event (AE) | Trial comparisons |
| Montelukast 10 mg/Loratadine 10 mg vs Placebo: 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/NCT01673620
GET https://conductscience.org/api/trials/v1/NCT01673620/registered