Trial · NCT00898677

Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)

NCT00898677, Phase 3, Completed, Organon and Co; results first posted 2009-07-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030). Trials, record NCT00898677. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00898677

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)
NCT number: NCT00898677
Status: Completed
Phases: Phase 3
Enrollment: 1,268 participants, actual
Lead sponsor: Organon and Co
Conditions: Migraine Headache
Interventions: rizatriptan benzoate, rizatriptan benzoate, Comparator: sumatriptan, Comparator: Placebo
First posted: 2009-05-12
Last updated: 2022-02-03
Results first posted: 2009-07-14

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pain Relief at 2 Hours After Dose	2 hours after dose	Patients 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 Dose	within 2 hours after dose	Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose
Secondary	Pain Free at 2 Hours After Dose	2 hours after dose	Patients pain free (defined as a reduction of headache severity to grade 0 \[no pain\]) at 2 hours after treatment. Each patient rated headache severity on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).
Secondary	Functional Status at 2 Hours After Dose	2 hours after dose	Patients with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each patient rated functional disability on a 4-grade scale (0 = no functional disability; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 = unable to carry out daily activities, requires bed rest).
Secondary	Nausea at 2 Hours After Dose	2 hours after dose	Patients who recorded the presence or absence of nausea 2 hours after dose

Source ClinicalTrials.gov

Outcomes5

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 Dose	2 hours after dose	An all-patients-treated approach was used in the primary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication. Missing values in the treatment phase (i.e., after the baseline phase) were imputed by carrying forward the preceding values in the same phase.	Participants	NUMBER
PRIMARY	Time to Relief Within 2 Hours After Dose	within 2 hours after dose	An all-patients-treated approach was used in the primary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication.	Participants	NUMBER
SECONDARY	Pain Free at 2 Hours After Dose	2 hours after dose	An all-patients-treated approach was used in the secondary analysis, including all patients who had at least one assessment of pain severity within 2 hours after test medication. Missing values in the treatment phase (i.e., after the baseline phase) were imputed by carrying forward the preceding values in the same phase.	Participants	NUMBER
SECONDARY	Functional Status at 2 Hours After Dose	2 hours after dose	An all-patients-treated approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.	Participants	NUMBER
SECONDARY	Nausea at 2 Hours After Dose	2 hours after dose	An all-patients-treated approach was used in the secondary analysis. Missing data were replaced by carrying forward the preceding value.	participants	NUMBER

Source ClinicalTrials.gov

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Pain Relief at 2 Hours After Dose	Rizatriptan 5 mg	2-hour pain relief	99	Participants
Pain Relief at 2 Hours After Dose	Rizatriptan 10 mg	2-hour pain relief	258	Participants
Pain Relief at 2 Hours After Dose	Sumatriptan 100 mg	2-hour pain relief	239	Participants
Pain Relief at 2 Hours After Dose	Placebo	2-hour pain relief	64	Participants
Pain Relief at 2 Hours After Dose	Rizatriptan 5 mg	No 2-hour pain relief	65	Participants
Pain Relief at 2 Hours After Dose	Rizatriptan 10 mg	No 2-hour pain relief	127	Participants
Pain Relief at 2 Hours After Dose	Sumatriptan 100 mg	No 2-hour pain relief	148	Participants
Pain Relief at 2 Hours After Dose	Placebo	No 2-hour pain relief	95	Participants
Time to Relief Within 2 Hours After Dose	Rizatriptan 5 mg	First pain relief within 2 hrs	102	Participants
Time to Relief Within 2 Hours After Dose	Rizatriptan 10 mg	First pain relief within 2 hrs	265	Participants

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Rizatriptan 5 mg	180
Overall Study	STARTED	Rizatriptan 10 mg	455
Overall Study	STARTED	Sumatriptan 100 mg	455
Overall Study	STARTED	Placebo	178
Overall Study	Patients Treated	Rizatriptan 5 mg	164
Overall Study	Patients Treated	Rizatriptan 10 mg	387
Overall Study	Patients Treated	Sumatriptan 100 mg	388
Overall Study	Patients Treated	Placebo	160
Overall Study	COMPLETED	Rizatriptan 5 mg	163
Overall Study	COMPLETED	Rizatriptan 10 mg	386

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events176

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
other	Asthenia/Fatigue	General disorders	Rizatriptan 5 mg	4	164
other	Asthenia/Fatigue	General disorders	Rizatriptan 10 mg	30	387
other	Asthenia/Fatigue	General disorders	Sumatriptan 100 mg	32	388
other	Asthenia/Fatigue	General disorders	Placebo	6	160
other	Chills	General disorders	Rizatriptan 5 mg	3	164
other	Chills	General disorders	Rizatriptan 10 mg	3	387
other	Chills	General disorders	Sumatriptan 100 mg	6	388
other	Chills	General disorders	Placebo	1	160
other	Cold Sensation	General disorders	Rizatriptan 5 mg	2	164
other	Cold Sensation	General disorders	Rizatriptan 10 mg	4	387

1 to 10 of 176Source ClinicalTrials.gov

See all 176 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rizatriptan 5 mg
Total, all-cause mortality	Rizatriptan 10 mg
Total, all-cause mortality	Sumatriptan 100 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Rizatriptan 5 mg	62	164
Total, other adverse events	Rizatriptan 10 mg	159	387
Total, other adverse events	Sumatriptan 100 mg	188	388
Total, other adverse events	Placebo	51	160
Total, serious adverse events	Rizatriptan 5 mg	1	164
Total, serious adverse events	Rizatriptan 10 mg	0	387

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
11284463	RESULT	PubMed
19222588	BACKGROUND	PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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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