Trial · NCT00250458

Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea

NCT00250458, Phase 3, Completed, Organon and Co; results first posted 2010-06-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea. Trials, record NCT00250458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00250458

On this page

Trial

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

Title: Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea
NCT number: NCT00250458
Status: Completed
Phases: Phase 3
Enrollment: 346 participants, actual
Lead sponsor: Organon and Co
Conditions: Migraine
Interventions: Comparator: Rizatriptan, Comparator: Placebo
First posted: 2005-11-08
Last updated: 2022-02-03
Results first posted: 2010-06-23

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Participants With Elimination of Nausea at 2 Hours Postdose	At 2 hours after treatment	Participants reporting the absence of nausea at 2 hours post treatment. Absence or presence of nausea was recorded by the participants in an electronic diary. Absence is defined as no nausea at 2 hours post-treatment.
Secondary	Participants With Pain Relief at 2 Hours Postdose	2 hours after treatment	Participants reporting pain relief defined as a reduction of pain 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.

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	Participants With Elimination of Nausea at 2 Hours Postdose	At 2 hours after treatment	Full Analysis Set (FAS): The FAS population included all randomized and treated Participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).	Participants	NUMBER
SECONDARY	Participants With Pain Relief at 2 Hours Postdose	2 hours after treatment	Full Analysis Set (FAS): The FAS population included all randomized and treated Participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).	Participants	NUMBER

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Category	Value	Units
Participants With Elimination of Nausea at 2 Hours Postdose	Rizatriptan 10 mg	No Nausea at 2 Hours	130	Participants
Participants With Elimination of Nausea at 2 Hours Postdose	Placebo	No Nausea at 2 Hours	57	Participants
Participants With Elimination of Nausea at 2 Hours Postdose	Rizatriptan 10 mg	Nausea at 2 Hours	55	Participants
Participants With Elimination of Nausea at 2 Hours Postdose	Placebo	Nausea at 2 Hours	35	Participants
Participants With Pain Relief at 2 Hours Postdose	Rizatriptan 10 mg	2-Hour Pain Relief	129	Participants
Participants With Pain Relief at 2 Hours Postdose	Placebo	2-Hour Pain Relief	50	Participants
Participants With Pain Relief at 2 Hours Postdose	Rizatriptan 10 mg	No 2-Hour Pain Relief	56	Participants
Participants With Pain Relief at 2 Hours Postdose	Placebo	No 2-Hour Pain Relief	42	Participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Rizatriptan 10 mg	232
Overall Study	STARTED	Placebo	114
Overall Study	COMPLETED	Rizatriptan 10 mg	200
Overall Study	COMPLETED	Placebo	97
Overall Study	NOT COMPLETED	Rizatriptan 10 mg	32
Overall Study	NOT COMPLETED	Placebo	17

Source ClinicalTrials.gov

Adverse events66

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	Palpitations	Cardiac disorders	Rizatriptan 10 mg	1	200
other	Palpitations	Cardiac disorders	Placebo	0	97
other	Vision blurred	Eye disorders	Rizatriptan 10 mg	2	200
other	Vision blurred	Eye disorders	Placebo	0	97
other	Abdominal pain upper	Gastrointestinal disorders	Rizatriptan 10 mg	1	200
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	0	97
other	Diarrhoea	Gastrointestinal disorders	Rizatriptan 10 mg	2	200
other	Diarrhoea	Gastrointestinal disorders	Placebo	0	97
other	Dry mouth	Gastrointestinal disorders	Rizatriptan 10 mg	2	200
other	Dry mouth	Gastrointestinal disorders	Placebo	0	97

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rizatriptan 10 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Rizatriptan 10 mg	30	200
Total, other adverse events	Placebo	4	97
Total, serious adverse events	Rizatriptan 10 mg	0	200
Total, serious adverse events	Placebo	0	97

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
18047500	BACKGROUND

Source 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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Rizatriptan 10 mg vs Placebo: serious adverse events

Source 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.

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.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00250458

GET https://conductscience.org/api/trials/v1/NCT00250458/events?page=2

API reference For AI assistants