Trial · NCT00897104
MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)
NCT00897104, Phase 3, Completed, Organon and Co; results first posted 2010-07-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029). Trials, record NCT00897104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00897104
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)
- NCT number
- NCT00897104
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 933 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Migraine Headache
- Interventions
- rizatriptan benzoate (MK0462), Comparator: sumatriptan, Comparator: Placebo
- First posted
- 2009-05-12
- Last updated
- 2022-02-03
- Results first posted
- 2010-07-23
- Limitations and caveats
- No limitations were encountered in this study.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Relief at 2 Hours After Treatment | 2 hours after treatment | Participants reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment |
| Primary | Time to Relief Within 2 Hours After Treatment | within 2 hours after treatment | Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg). |
| Secondary | Pain Free at 2 Hours After Treatment | 2 hours after treatment | Participants pain free (defined as a reduction of headache severity to grade 0 \[no pain\]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain). |
| Secondary | Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities | 2 hours after treatment | Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest). |
| Secondary | Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment | 2 hours after treatment | Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment. |
| Secondary | Participants Who Used Escape Medication 2 Hours After the Treatment Dose | 2 hours after treatment | Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication. |
| Secondary | Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1]) | 24 hours | Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Relief at 2 Hours After Treatment | 2 hours after treatment | An all-participants-treated approach was used in the primary analysis, including all participants who had at least one assessment of pain severity within 2 hours after dose. Missing data were replaced by carrying forward the preceding value. | Participants | NUMBER |
| PRIMARY | Time to Relief Within 2 Hours After Treatment | within 2 hours after treatment | An all-participants-treated approach was used in the primary analysis, including all participants who had at least one assessment of pain severity within 2 hours after test medication. | Participants | NUMBER |
| SECONDARY | Pain Free at 2 Hours After Treatment | 2 hours after treatment | An all-participants-treated approach was used in the secondary analysis, including all participants who had at least one assessment of pain severity within 2 hours after test medication. Missing data were replaced by carrying forward the preceding value. | Participants | NUMBER |
| SECONDARY | Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities | 2 hours after treatment | An all-participants-treated approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value. | Participants | NUMBER |
| SECONDARY | Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment | 2 hours after treatment | All-participants-treated approach was used. Missing data were replaced by carrying forward the preceding value. Participants Analyzed For Nausea: Rizatriptan 348; Sumatriptan 352; Placebo 78. Participants Analyzed for Vomiting: Rizatriptan 342; Sumatriptan 342; Placebo 73. Number of participants analyzed is correct for the other categories. | Participants | NUMBER |
| SECONDARY | Participants Who Used Escape Medication 2 Hours After the Treatment Dose | 2 hours after treatment | An all-participants-treated approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value. | Participants | NUMBER |
| SECONDARY | Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1]) | 24 hours | The duration of relief, or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1), was calculated for responders who had a headache recurrence. | Hours | MEAN |
Source ClinicalTrials.gov
Results by group69
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain Relief at 2 Hours After Treatment | Rizatriptan 5 mg | 2-hour pain relief | 223 | Participants | |
| Pain Relief at 2 Hours After Treatment | Sumatriptan 5 mg | 2-hour pain relief | 238 | Participants | |
| Pain Relief at 2 Hours After Treatment | Placebo | 2-hour pain relief | 18 | Participants | |
| Pain Relief at 2 Hours After Treatment | Rizatriptan 5 mg | No 2-hour pain relief | 129 | Participants | |
| Pain Relief at 2 Hours After Treatment | Sumatriptan 5 mg | No 2-hour pain relief | 118 | Participants | |
| Pain Relief at 2 Hours After Treatment | Placebo | No 2-hour pain relief | 62 | Participants | |
| Time to Relief Within 2 Hours After Treatment | Rizatriptan 5 mg | First pain relief within 2 hrs | 231 | Participants | |
| Time to Relief Within 2 Hours After Treatment | Sumatriptan 5 mg | First pain relief within 2 hrs | 247 | Participants | |
| Time to Relief Within 2 Hours After Treatment | Placebo | First pain relief within 2 hrs | 24 | Participants | |
| Time to Relief Within 2 Hours After Treatment | Rizatriptan 5 mg | Pain relief did not occur within 2 hrs | 121 | Participants |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rizatriptan 5 mg | 418 | |
| Overall Study | STARTED | Sumatriptan 5 mg | 428 | |
| Overall Study | STARTED | Placebo | 87 | |
| Overall Study | Participants Treated | Rizatriptan 5 mg | 355 | |
| Overall Study | Participants Treated | Sumatriptan 5 mg | 357 | |
| Overall Study | Participants Treated | Placebo | 80 | |
| Overall Study | Participants Not Treated | Rizatriptan 5 mg | 63 | |
| Overall Study | Participants Not Treated | Sumatriptan 5 mg | 71 | |
| Overall Study | Participants Not Treated | Placebo | 7 | |
| Overall Study | COMPLETED | Rizatriptan 5 mg | 354 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events84
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 | Asthenia/Fatigue | General disorders | Rizatriptan 5 mg | 25 | 355 | |
| other | Asthenia/Fatigue | General disorders | Sumatriptan 5 mg | 18 | 357 | |
| other | Asthenia/Fatigue | General disorders | Placebo | 1 | 80 | |
| other | Fever | General disorders | Rizatriptan 5 mg | 1 | 355 | |
| other | Fever | General disorders | Sumatriptan 5 mg | 1 | 357 | |
| other | Fever | General disorders | Placebo | 1 | 80 | |
| other | Pain, Abdominal | General disorders | Rizatriptan 5 mg | 4 | 355 | |
| other | Pain, Abdominal | General disorders | Sumatriptan 5 mg | 5 | 357 | |
| other | Pain, Abdominal | General disorders | Placebo | 0 | 80 | |
| other | Pain, Chest | General disorders | Rizatriptan 5 mg | 8 | 355 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rizatriptan 5 mg | ||
| Total, all-cause mortality | Sumatriptan 5 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Rizatriptan 5 mg | 92 | 355 |
| Total, other adverse events | Sumatriptan 5 mg | 108 | 357 |
| Total, other adverse events | Placebo | 16 | 80 |
| Total, serious adverse events | Rizatriptan 5 mg | 0 | 355 |
| Total, serious adverse events | Sumatriptan 5 mg | 0 | 357 |
| Total, serious adverse events | Placebo | 0 | 80 |
Source ClinicalTrials.gov
Papers3
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.
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