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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00250458
Other study ID # 0462-074
Secondary ID 2005_081
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2006
Est. completion date October 2006

Study information

Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.


Recruitment information / eligibility

Status Completed
Enrollment 346
Est. completion date October 2006
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 6-month history of migraine, moderate to severe migraine attacks with nausea, 1-6 migraine attacks per month Exclusion Criteria: - Heart disease, high blood pressure

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Comparator: Rizatriptan
One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack.
Comparator: Placebo
One dose matching placebo to Rizatriptan to treat one migraine attack.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

Freitag F, Taylor FR, Hamid MA, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Elimination of migraine-associated nausea in patients treated with rizatriptan orally disintegrating tablet (ODT): a randomized, double-blind, placebo-controlled study. Headache. 2008 Mar;48(3):368-77. Epub 2007 Nov 28. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Participants With Elimination of Nausea at 2 Hours Postdose 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. At 2 hours after treatment
Secondary Participants With Pain Relief at 2 Hours Postdose 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. 2 hours after treatment
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