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

Migraine Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Elimination of Migraine-Associated Nausea in Migraine Patients Treated With Rizatriptan Orally Disintegrating Tablet (ODT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250458
• Other study ID #: 0462-074
• Secondary ID: 2005_081
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

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