Trial · NCT00356603
Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan
NCT00356603, Phase 3, Completed, GlaxoSmithKline; results first posted 2017-11-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan. Trials, record NCT00356603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00356603
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan
- NCT number
- NCT00356603
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 75 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Migraine Disorders
- Interventions
- Sumatriptan Succinate
- First posted
- 2006-07-26
- Last updated
- 2018-09-04
- Results first posted
- 2017-11-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache) | 30 minutes or 60 Minutes after each administration | Headache relief rate was the percentage of participants who showed effectiveness 60 minutes post dose (migraine) or 30 minutes post dose (cluster headache). Data for participants with percentage effectiveness along with 95% confidence interval has been presented. |
| Secondary | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Up to 2 months | The subject-rated acceptability of sumatriptan succinate injection 3 mg kit product had three questions, question 1 was "Was the kit product easy to use?", question 2 was "Do you want to use the kit product in the future?" and question 3 was "Do you consider that the kit product is necessary for the treatment of your illness?". The responses were given as yes or no. Data for number of participants who responded to the three questions as yes or no has been presented. |
| Secondary | Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate | Up to 2 months | The investigator/sub investigator-rated successful self-injection rate was the percentage of participants who were able to use the kit as directed by the investigator/ sub investigator. The response was given as yes or no. Data for percentage of participants who were actually able to use the kit as directed has been presented. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache) | 30 minutes or 60 Minutes after each administration | Full Analysis Set (FAS) Population included patients who self-administered the study product and have at least one efficacy data. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Up to 2 months | FAS Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Investigator/Sub Investigator-rated Successful Self-injection Rate | Up to 2 months | FAS Population. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache) | Migraine | 93.9 | 95% Confidence Interval 79.8 to 99.3 | Percentage of participants | |
| Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache) | Cluster Headache | 93.9 | 95% Confidence Interval 79.8 to 99.3 | Percentage of participants | |
| Percentage of Participants With Headache Relief at 60 Minutes Post Dose(Migraine) or 30 Minutes Post Dose(Cluster Headache) | Migraine + Cluster Headache | 93.9 | 95% Confidence Interval 85.2 to 98.3 | Percentage of participants | |
| Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Migraine | Question 1: Yes | 32 | Participants | |
| Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Cluster Headache | Question 1: Yes | 33 | Participants | |
| Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Migraine + Cluster Headache | Question 1: Yes | 65 | Participants | |
| Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Migraine | Question 1: No | 1 | Participants | |
| Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Cluster Headache | Question 1: No | 0 | Participants | |
| Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Migraine + Cluster Headache | Question 1: No | 1 | Participants | |
| Number of Participants With Subject-rated Acceptability of the Sumatriptan 3mg Kit Product | Migraine | Question 2: Yes | 31 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Migraine | 39 | |
| Overall Study | STARTED | Cluster Headache | 36 | |
| Overall Study | COMPLETED | Migraine | 33 | |
| Overall Study | COMPLETED | Cluster Headache | 33 | |
| Overall Study | NOT COMPLETED | Migraine | 6 | |
| Overall Study | NOT COMPLETED | Cluster Headache | 3 |
Source ClinicalTrials.gov
Adverse events51
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 | Malaise | General disorders | Migraine | 1 | 33 | |
| other | Malaise | General disorders | Cluster Headache | 2 | 33 | |
| other | Malaise | General disorders | Migraine + Cluster Headache | 3 | 66 | |
| other | Nausea | Gastrointestinal disorders | Migraine | 1 | 33 | |
| other | Nausea | Gastrointestinal disorders | Cluster Headache | 2 | 33 | |
| other | Nausea | Gastrointestinal disorders | Migraine + Cluster Headache | 3 | 66 | |
| other | Blood creatine phosphokinase increased | Investigations | Migraine | 0 | 33 | |
| other | Blood creatine phosphokinase increased | Investigations | Cluster Headache | 3 | 33 | |
| other | Blood creatine phosphokinase increased | Investigations | Migraine + Cluster Headache | 3 | 66 | |
| other | Asthenia | General disorders | Migraine | 1 | 33 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Migraine | 0 | 33 |
| Total, all-cause mortality | Cluster Headache | 0 | 33 |
| Total, all-cause mortality | Migraine + Cluster Headache | 0 | 66 |
| Total, other adverse events | Migraine | 5 | 33 |
| Total, other adverse events | Cluster Headache | 10 | 33 |
| Total, other adverse events | Migraine + Cluster Headache | 15 | 66 |
| Total, serious adverse events | Migraine | 0 | 33 |
| Total, serious adverse events | Cluster Headache | 0 | 33 |
| Total, serious adverse events | Migraine + Cluster Headache | 0 | 66 |
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/NCT00356603
GET https://conductscience.org/api/trials/v1/NCT00356603/results?page=2