Re-examination Study of EMEND (Aprepitant) (MK-0869-184)

NCT01074255 | Completed Results

• 2 other identifiers: 0869-184MK-0869-184
• Study Type: observational
• Target: 3,546
• Locations: 0 countries
• Sites: N/A

Brief Summary

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation. Its aim is to reconfirm the clinical usefulness of EMEMD (aprepitant) through collecting the safety information according to the Re-examination Regulation for New Drugs.

Conditions

Chemotherapy-induced Nausea and Vomiting

Keywords

Nausea; Vomiting; Chemotherapy; Post-chemotherapy

Outcome Measures

Primary Outcomes (1)

• Investigator Global Assessment of Participants' Response to Therapy With EMEND (Aprepitant) for the Prevention of Acute and Delayed Nausea Following Chemotherapy

  The investigators assessed a participant's response to therapy with EMEND to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of chemotherapy when used concomitantly with other antiemetics. The response categories were: excellent (best possible anticipated response, considering the severity and stage of disease), good (good response, but less than the best possible anticipated response), fair (definite response, but could be better), poor (minimal response, unacceptable), or none (no response, absence of drug effect).

  Up to 14 days following the cessation of treatment

Study Arms (1)

Korean Participants Treated With EMEND (aprepitant)

Participants receiving EMEND on Treatment Days 1, 2, and 3 concomitantly with a corticosteroid and a 5-hydroxytryptamine 3 (5-HT3) antagonist.

Drug: EMEND

Interventions

EMEND DRUG

EMEND (Aprepitant,125 mg oral capsules) is administered 1 hour prior to chemotherapy on treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist.

Also known as: Aprepitant, MK-0869

Korean Participants Treated With EMEND (aprepitant)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Korean patients treated with EMEND in usual practice.

You may qualify if:

• Participants who are treated with EMEND for the first time as per the EMEND label

You may not qualify if:

• Contraindication to EMEND

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Vomiting; Nausea

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 24, 2010
• Study Start: April 1, 2007
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: April 21, 2015
• Results First Posted: October 5, 2012

Record last verified: 2015-04