Trial · NCT02279082
DFN-02 Open Label Safety Study in Patients With Acute Migraine
NCT02279082, Phase 3, Completed, Dr. Reddy's Laboratories Limited, India; results first posted 2017-08-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. DFN-02 Open Label Safety Study in Patients With Acute Migraine. Trials, record NCT02279082. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02279082
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DFN-02 Open Label Safety Study in Patients With Acute Migraine
- NCT number
- NCT02279082
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 167 participants, actual
- Lead sponsor
- Dr. Reddy's Laboratories Limited, India
- Conditions
- Acute Migraine
- Interventions
- DFN-02
- First posted
- 2014-10-30
- Last updated
- 2018-03-09
- Results first posted
- 2017-08-28
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 With Treatment Emergent Adverse Events | 6 months |
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 With Treatment Emergent Adverse Events | 6 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1
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 Treatment Emergent Adverse Events | DFN-02 | 120 | 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 | DFN-02 | 167 | |
| Overall Study | COMPLETED | DFN-02 | 134 | |
| Overall Study | NOT COMPLETED | DFN-02 | 33 |
Source ClinicalTrials.gov
Adverse events11
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 | dysgeusia | Nervous system disorders | DFN-02 (Single Arm, Open Label) | 35 | 167 | 232 |
| other | Application site pain | General disorders | DFN-02 (Single Arm, Open Label) | 51 | 167 | 568 |
| other | Application Site Reaction | General disorders | DFN-02 (Single Arm, Open Label) | 9 | 167 | 32 |
| other | Upper Respiratory Tract Infection | Infections and infestations | DFN-02 (Single Arm, Open Label) | 18 | 167 | 24 |
| other | Nasopharyngitis | Infections and infestations | DFN-02 (Single Arm, Open Label) | 12 | 167 | 13 |
| other | Sinusitis | Infections and infestations | DFN-02 (Single Arm, Open Label) | 11 | 167 | 12 |
| serious | Diverticulitis | Gastrointestinal disorders | DFN-02 (Single Arm, Open Label) | 1 | 167 | |
| serious | cholecystitis | Gastrointestinal disorders | DFN-02 (Single Arm, Open Label) | 1 | 167 | |
| serious | menometrorrhagia | Reproductive system and breast disorders | DFN-02 (Single Arm, Open Label) | 1 | 167 | |
| serious | pyelonephritis | Renal and urinary disorders | DFN-02 (Single Arm, Open Label) | 1 | 167 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DFN-02 (Single Arm, Open Label) | 0 | 167 |
| Total, other adverse events | DFN-02 (Single Arm, Open Label) | 120 | 167 |
| Total, serious adverse events | DFN-02 (Single Arm, Open Label) | 4 | 167 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT02279082
GET https://conductscience.org/api/trials/v1/NCT02279082/registered