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TAK-954 for Gastrointestinal Dysfunction

Phase 2
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (surgery) up to day 24 postsurgery (10 days of treatment period postsurgery plus 14-day observation period post last dose for recurrence of symptoms)
Awards & highlights

Study Summary

A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (surgery) up to day 24 postsurgery (10 days of treatment period postsurgery plus 14-day observation period post last dose for recurrence of symptoms)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (surgery) up to day 24 postsurgery (10 days of treatment period postsurgery plus 14-day observation period post last dose for recurrence of symptoms) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time From End of the Surgery to Resolution of Upper and Lower Gastrointestinal (GI) Function Postsurgery as Assessed by the Investigator
Secondary outcome measures
Observed Plasma Concentration of TAK-954 at the End of Infusion on Day 1
Percentage of Participants Requiring Insertion of Nasogastric (NG) Tube Postsurgery
Percentage of Participants With Postoperative Gastrointestinal Dysfunction (POGD) >= 5 Days as Assessed by the Investigator
+6 more

Side effects data

From 2019 Phase 2 trial • 36 Patients • NCT03281577
40%
Nausea
30%
Abdominal pain
20%
Diarrhoea
20%
Viral infection
10%
Vomiting
10%
Headache
10%
Chills
10%
Flatulence
100%
80%
60%
40%
20%
0%
Study treatment Arm
TAK-954 0.1 mg
TAK-954 0.3 mg
TAK-954 1 mg
Placebo

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: TAK-954 0.5 mg/100 mL + PlaceboExperimental Treatment2 Interventions
TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.
Group II: TAK-954 0.5 mg/100 mLExperimental Treatment1 Intervention
TAK-954 0.5 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.
Group III: TAK-954 0.1 mg/100 mL + PlaceboExperimental Treatment2 Interventions
TAK-954 0.1 mg/100 mL, 60-minute infusion, IV, once presurgery on Day 1 and once daily placebo infusions postsurgery up to Day 10 or until resolution of upper and lower GI function.
Group IV: TAK-954 0.1 mg/100 mLExperimental Treatment1 Intervention
TAK-954 0.1 milligrams per 100 milliliters (mg/100 mL), 60-minute infusion, IV, once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.
Group V: PlaceboPlacebo Group1 Intervention
TAK-954 placebo-matching, 60-minute infusion, intravenously (IV), once presurgery on Day 1 and once daily postsurgery until return of upper and lower GI function or for up to 10 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-954
2019
Completed Phase 2
~320
TAK-954 Placebo
2019
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
11,821 Total Patients Enrolled
TakedaLead Sponsor
1,201 Previous Clinical Trials
4,178,074 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,206 Previous Clinical Trials
489,709 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery
2019. "A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03827655.
~34 spots leftby Apr 2025
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