A study to evaluate the safety and effect of Akynzeo�® to treat nausea and vomiting caused after chemotherapy.

Phase 4

Completed

• Conditions: Health Condition 1: R112- Nausea with vomiting, unspecified

• Registration Number: CTRI/2020/02/023586
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-12-30
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 360

Inclusion Criteria

1. Patient scheduled to receive a highly or moderately emetogenic chemotherapy (HEC/MEC).

2.Scheduled to receive Akynzeo as per current practice, at the judgment of Investigator.

3. Male/females patients age above �18 years

4. Willing to be part of study and for follow up.

5. Willing to provide written inform consent form.

Exclusion Criteria

1. Radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5.

2. Bone marrow or stem-cell transplant patients.

3. Serious cardiovascular disease history or predisposition to cardiac conduction abnormalities.

4. Vomiting, retching, or more than mild nausea within 24 h before day 1.

5. Women of child bearing potential who are pregnant, planning on becoming pregnant or breast feeding.

6. Hypersensitivity to active substances, excipients or other ingredients of Akynzeo (NEPA).

7. Patient currently enrolled in another clinical trial where antiemetic treatment is pre-specified by the study protocol.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Overall complete response rate (0 to 120 hrs.) <br/ ><br>2. Occurrence /Frequency or incident rate of treatment emergent adverse eventsTimepoint: 1. upto 120hrs <br/ ><br>2. Overall study duration <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1. Complete response rate during acute phase (0 to 24 hrs.) <br/ ><br>2. Complete response rate during delayed phase (24 to 120 hrs.) <br/ ><br>3. Complete control rate during overall phase (0 to 120 hrs.) <br/ ><br>4. Severity of nausea assessed using a Visual Analogue Scale (VAS)Timepoint: 1. upto 24hrs <br/ ><br>2. 24hrs to 120hrs <br/ ><br>3. 0hrs to 120hrs <br/ ><br>