NCT02954848 is a Phase 3 clinical trial of TAK-438 10 mg in Non-erosive Gastroesophageal Reflux Disease, sponsored by Takeda.

Who is sponsoring NCT02954848?

NCT02954848 is sponsored by Takeda.

What drugs are being tested in NCT02954848?

Interventions in NCT02954848: Placebo, TAK-438 10 mg.

What condition does NCT02954848 study?

NCT02954848 studies Non-erosive Gastroesophageal Reflux Disease.

Is NCT02954848 still recruiting?

NCT02954848 is currently completed. Last updated 2 August 2019.

Are results published for NCT02954848?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-08-02 · How we verify

NCT02954848

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 3 Study of TAK-438 10 mg in the Treatment of Non-Erosive Gastroesophageal Reflux Disease (NERD)

Completed Phase 3 Results posted Last updated 2 August 2019

What this trial tests

Phase 3 trial testing Placebo in Non-erosive Gastroesophageal Reflux Disease in 484 participants. Completed in 26 February 2018.

Timeline

15 November 2016

Primary endpoint
25 February 2018

26 February 2018

Quick facts

Lead sponsor	Takeda
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	484
Start date	15 November 2016
Primary completion	25 February 2018
Estimated completion	26 February 2018
Sites	30 locations across Japan

Drugs / interventions tested

Placebo
TAK-438 10 mg — full drug profile →

Conditions studied

Non-erosive Gastroesophageal Reflux Disease — all drugs for Non-erosive Gastroesophageal Reflux Disease →

Sponsor

Takeda — full company profile →

Who can join

20 and older, any sex, with Non-erosive Gastroesophageal Reflux Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Days Without Symptoms of Heartburn Primary · Up to Week 4

Heartburn symptoms were collected by participant diaries. Participants recorded the presence and severity (Without symptom \[No symptom: 0, No hindrance to daily activities: 1\], With symptom \[Mild: 2, Moderate: 3, Severe: 4\]) of heartburn in a daily participant diary. The score range was 0-4, with the higher scores reflecting the greater severity. Reported data was the percentage of days for each group, calculated by the number of days without heartburn divided by the number of days of treatment period.

Group	Value	95% CI
Placebo	61.50	0.0 – 100.0
TAK-438 10 mg	72.55	0.0 – 100.0

Cumulative Rate of Improvement in Symptoms of Heartburn Primary · Day 0 to Day 24

Heartburn symptoms were collected by participant diaries. Participants recorded the presence and severity (Without symptom \[No symptom: 0, No hindrance to daily activities: 1\], With symptom \[Mild: 2, Moderate: 3, Severe: 4\]) of heartburn in a daily participant diary. The score range was 0-4, with the higher scores reflecting the greater severity. Cumulative rate of improvement was calculated as percentage of participants who experienced symptom improvement. Symptom improvement was defined as symptoms experienced on less than 2 days of the last 7 days. The cumulative data was collected betw

Day 0

Group	Value	95% CI
Placebo	0.0
TAK-438 10 mg	0.0

Day 1

Group	Value	95% CI
Placebo	14.7
TAK-438 10 mg	23.1

Day 2

Group	Value	95% CI
Placebo	15.9
TAK-438 10 mg	24.4

Day 3

Group	Value	95% CI
Placebo	16.3
TAK-438 10 mg	25.2

Day 4

Group	Value	95% CI
Placebo	17.6
TAK-438 10 mg	26.1

Day 5

Group	Value	95% CI
Placebo	18.8
TAK-438 10 mg	28.2

Day 6

Group	Value	95% CI
Placebo	19.2
TAK-438 10 mg	30.4

Day 7

Group	Value	95% CI
Placebo	20.0
TAK-438 10 mg	32.5

Severity of Symptoms of Heartburn Primary · Up to Week 4

Group	Value	95% CI
Placebo	1.140	0.00 – 2.82
TAK-438 10 mg	1.070	0.00 – 3.67

Percentage of Days Without Symptoms of Heartburn in Subgroup Stratified by Response (Improved or Not Improved) at Week 2 Secondary · Up to Week 4

Participants recorded the presence and severity of heartburn in a daily participant diary. Percentage of days without heartburn was calculated in each subgroup of the response (improved or not improved) according to Criteria 1, i.e. Improved: the participants experienced heartburn on less than 2 days of the 7 days prior to Week 2 \[Day 8 through Day 14\]; Not improved: the participants experienced heartburn on 2 days or more of the 7 days prior to Week 2 \[Day 8 through Day 14\] and Criteria 2, i.e. Improved: the proportion of days the participants experienced heartburn during the treatment pe

Criteria 1, Improved

Group	Value	95% CI
Placebo	92.00	41.4 – 100.0
TAK-438 10 mg	96.00	46.4 – 100.0

Criteria 1, Not Improved

Group	Value	95% CI
Placebo	50.95	0.0 – 92.9
TAK-438 10 mg	48.05	0.0 – 92.9

Criteria 2, Improved

Group	Value	95% CI
Placebo	71.40	3.3 – 100.0
TAK-438 10 mg	81.15	14.3 – 100.0

Criteria 2, Not Improved

Group	Value	95% CI
Placebo	39.30	0.0 – 83.3
TAK-438 10 mg	24.15	0.0 – 84.0

Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Response (Improved Per Criteria 1) at Week 2 Secondary · Day 0 to Day 22

Participants recorded presence and severity (Without symptom \[No symptom:0, No hindrance to daily activities:1\], With symptom \[Mild:2, Moderate:3, Severe:4\]) of heartburn in daily participant diary. The score range was 0-4, with the higher scores reflecting the greater severity. Cumulative rate of improvement was calculated as percentage of participants who experienced symptom improvement. The response was evaluated per Criteria 1, i.e. Improved: the participants experienced heartburn on less than 2 days of the 7 days prior to Week 2 \[Day 8 through Day 14\]; Not improved: the participants

Day 0

Group	Value	95% CI
Placebo	0.0
TAK-438 10 mg	0.0

Day 1

Group	Value	95% CI
Placebo	43.4
TAK-438 10 mg	55.6

Day 2

Group	Value	95% CI
Placebo	47.0
TAK-438 10 mg	58.6

Day 3

Group	Value	95% CI
Placebo	48.2
TAK-438 10 mg	60.6

Day 4

Group	Value	95% CI
Placebo	51.8
TAK-438 10 mg	62.6

Day 5

Group	Value	95% CI
Placebo	55.4
TAK-438 10 mg	67.7

Day 6

Group	Value	95% CI
Placebo	56.6
TAK-438 10 mg	72.7

Day 7

Group	Value	95% CI
Placebo	59.0
TAK-438 10 mg	77.8

Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Response (Not Improved Per Criteria 1) at Week 2 Secondary · Day 0 to Day 24

Participants recorded presence and severity (Without symptom \[No symptom:0, No hindrance to daily activities:1\], With symptom \[Mild:2, Moderate:3, Severe:4\]) of heartburn in daily participant diary. The score range was 0-4, with the higher scores reflecting the greater severity. Cumulative rate of improvement is calculated as percentage of participants who experienced symptom improvement. The response was evaluated per Criteria 1, i.e. Improved: the participants experienced heartburn on less than 2 days of the 7 days prior to Week 2 \[Day 8 through Day 14\]; Not improved: the participants

Day 0

Group	Value	95% CI
Placebo	0.0
TAK-438 10 mg	0.0

Day 9

Group	Value	95% CI
Placebo	3.7
TAK-438 10 mg	2.2

Day 10

Group	Value	95% CI
Placebo	NA
TAK-438 10 mg	4.4

Day 11

Group	Value	95% CI
Placebo	6.8
TAK-438 10 mg	8.1

Day 12

Group	Value	95% CI
Placebo	9.3
TAK-438 10 mg	12.6

Day 13

Group	Value	95% CI
Placebo	11.7
TAK-438 10 mg	18.5

Day 14

Group	Value	95% CI
Placebo	14.2
TAK-438 10 mg	22.2

Day 15

Group	Value	95% CI
Placebo	15.4
TAK-438 10 mg	25.2

Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Response (Improved Per Criteria 2) at Week 2 Secondary · Day 0 to Day 24

Participants recorded presence and severity (Without symptom \[No symptom:0, No hindrance to daily activities:1\], With symptom \[Mild:2, Moderate:3, Severe:4\]) of heartburn in daily participant diary. The score range was 0-4, with higher scores reflecting the greater severity. Cumulative rate of improvement calculated as percentage of participants who experienced symptom improvement. Response evaluated per Criteria 2, i.e. Improved: proportion of days participant experienced heartburn during treatment period up to Week 2 \[Day 14\] was lower than that during run-in period; Not improved: prop

Day 0

Group	Value	95% CI
Placebo	0.0
TAK-438 10 mg	0.0

Day 1

Group	Value	95% CI
Placebo	21.4
TAK-438 10 mg	31.6

Day 2

Group	Value	95% CI
Placebo	23.2
TAK-438 10 mg	33.3

Day 3

Group	Value	95% CI
Placebo	23.8
TAK-438 10 mg	34.5

Day 4

Group	Value	95% CI
Placebo	25.6
TAK-438 10 mg	35.6

Day 5

Group	Value	95% CI
Placebo	26.2
TAK-438 10 mg	38.5

Day 6

Group	Value	95% CI
Placebo	26.8
TAK-438 10 mg	41.4

Day 7

Group	Value	95% CI
Placebo	28.0
TAK-438 10 mg	44.3

Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Response (Not Improved Per Criteria 2) at Week 2 Secondary · Day 0 to Day 24

Participants recorded presence and severity (Without symptom \[No symptom:0, No hindrance to daily activities:1\], With symptom \[Mild:2, Moderate:3, Severe:4\]) of heartburn in daily participant diary. The score range was 0-4, with higher scores reflecting the greater severity. Cumulative rate of improvement calculated as percentage of participants who experienced symptom improvement. The response evaluated per Criteria 2, i.e. Improved: proportion of days participant experienced heartburn during treatment period up to Week 2 \[Day 14\] was lower than that during run-in period; Not improved:

Day 0

Group	Value	95% CI
Placebo	0.0
TAK-438 10 mg	0.0

Day 5

Group	Value	95% CI
Placebo	2.6
TAK-438 10 mg	NA

Day 9

Group	Value	95% CI
Placebo	5.2
TAK-438 10 mg	1.6

Day 11

Group	Value	95% CI
Placebo	6.5
TAK-438 10 mg	NA

Day 12

Group	Value	95% CI
Placebo	NA
TAK-438 10 mg	4.9

Day 13

Group	Value	95% CI
Placebo	7.8
TAK-438 10 mg	8.2

Day 14

Group	Value	95% CI
Placebo	13.0
TAK-438 10 mg	14.8

Day 15

Group	Value	95% CI
Placebo	14.3
TAK-438 10 mg	18.0

Severity of Symptoms of Heartburn in Subgroup Stratified by Response (Improved or Not Improved) at Week 2 Secondary · Up to Week 4

Participants recorded the presence and severity (Without symptom \[No symptom: 0, No hindrance to daily activities: 1\], With symptom \[Mild: 2, Moderate: 3, Severe: 4\]) of heartburn in a daily participant diary. The score range was 0-4, the higher scores indicates greater severity. The severity was calculated in each subgroup of response (improved or not improved) according to Criteria 1, i.e. Improved: participants experienced heartburn on less than 2 days of the 7 days prior to Week 2 \[Day 8 through Day 14\]; Not improved: participants experienced heartburn on 2 days or more of the 7 days

Criteria 1, Improved

Group	Value	95% CI
Placebo	0.420	0.00 – 1.44
TAK-438 10 mg	0.310	0.00 – 1.56

Criteria 1, Not Improved

Group	Value	95% CI
Placebo	1.430	0.25 – 2.82
TAK-438 10 mg	1.420	0.14 – 2.64

Criteria 2, Improved

Group	Value	95% CI
Placebo	0.960	0.00 – 2.14
TAK-438 10 mg	0.675	0.00 – 2.04

Criteria 2, Not Improved

Group	Value	95% CI
Placebo	1.610	0.44 – 2.82
TAK-438 10 mg	1.740	0.43 – 3.67

Percentage of Days Without Symptoms of Heartburn in Subgroup Stratified by Endoscopic Findings (the Modified LA Classification Grade N or M) at Baseline Secondary · Up to Week 4

Heartburn symptoms were collected by participant diaries. Participants recorded the presence and severity (Without symptom \[No symptom: 0, No hindrance to daily activities: 1\], With symptom \[Mild: 2, Moderate: 3, Severe: 4\]) of heartburn in a daily participant diary. The score range was 0-4, higher scores indicates greater severity. The percentage was calculated in each subgroup of the endoscopic findings where Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity; Grade A: non-confluent mucosal breaks \<5mm in length; Grade B: non-conflu

Grade N

Group	Value	95% CI
Placebo	64.15	0.0 – 100.0
TAK-438 10 mg	76.70	0.0 – 100.0

Grade M

Group	Value	95% CI
Placebo	60.70	0.0 – 100.0
TAK-438 10 mg	67.90	0.0 – 100.0

Cumulative Rate of Improvement in Heartburn in Subgroup Stratified by Endoscopic Findings (the Modified LA Classification Grade N) at Baseline Secondary · Day 0 to Day 24

Participants recorded presence and severity (Without symptom \[No symptom:0, No hindrance to daily activities:1\], With symptom \[Mild:2, Moderate:3, Severe:4\]) of heartburn in participant diary. The score range was 0-4, higher scores indicates greater severity. Cumulative rate of improvement calculated as percentage of participants who experienced symptom improvement. Cumulative rate calculated in subgroup of Grade N per modified LA classification. Modified LA classification Grade N: normal mucosa; Grade M: minimal changes to mucosa; Grade A: nonconfluent mucosal breaks \<5mm in length; Grad

Day 0

Group	Value	95% CI
Placebo	0.0
TAK-438 10 mg	0.0

Day 1

Group	Value	95% CI
Placebo	18.3
TAK-438 10 mg	22.2

Day 2

Group	Value	95% CI
Placebo	NA
TAK-438 10 mg	23.5

Day 3

Group	Value	95% CI
Placebo	19.5
TAK-438 10 mg	24.7

Day 4

Group	Value	95% CI
Placebo	NA
TAK-438 10 mg	27.2

Day 5

Group	Value	95% CI
Placebo	23.2
TAK-438 10 mg	29.7

Day 6

Group	Value	95% CI
Placebo	24.4
TAK-438 10 mg	32.3

Day 7

Group	Value	95% CI
Placebo	26.8
TAK-438 10 mg	36.0

Cumulative Rate of Improvement in Heartburn in Subgroup Stratified by Endoscopic Findings (the Modified LA Classification Grade M) at Baseline Secondary · Day 0 to Day 24

Participants recorded presence and severity (Without symptom \[No symptom:0, No hindrance to daily activities:1\], With symptom \[Mild:2, Moderate:3, Severe:4\]) of heartburn in participant diary. Score range was 0-4, higher scores indicates greater severity. Cumulative rate of improvement calculated as percentage of participants who experienced symptom improvement. Cumulative rate calculated in subgroup of Grade M per modified LA classification. Modified LA classification Grade N: normal mucosa; Grade M: minimal changes to mucosa; Grade A: nonconfluent mucosal breaks \<5mm in length; Grade B:

Day 0

Group	Value	95% CI
Placebo	0.0
TAK-438 10 mg	0.0

Day 1

Group	Value	95% CI
Placebo	12.9
TAK-438 10 mg	23.6

Day 2

Group	Value	95% CI
Placebo	14.7
TAK-438 10 mg	24.9

Day 3

Group	Value	95% CI
Placebo	NA
TAK-438 10 mg	25.5

Day 4

Group	Value	95% CI
Placebo	16.6
TAK-438 10 mg	NA

Day 5

Group	Value	95% CI
Placebo	NA
TAK-438 10 mg	27.5

Day 6

Group	Value	95% CI
Placebo	NA
TAK-438 10 mg	29.4

Day 7

Group	Value	95% CI
Placebo	NA
TAK-438 10 mg	30.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Week 4. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 1/245 (0%)

Deaths: 0/245

TAK-438 10 mg

Serious: 0/238 (0%)

Deaths: 0/238

Serious adverse events (1 terms)

Reaction	System	Placebo	TAK-438 10 mg
Colitis ulcerative	Gastrointestinal disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Placebo	TAK-438 10 mg
Viral upper respiratory tract infection	Infections and infestations	—	—

Most-reported serious reactions: Colitis ulcerative.

Data from ClinicalTrials.gov NCT02954848 adverse events section.

Sponsor's own description

The purpose of this study was to evaluate the efficacy and safety of oral TAK-438 10 mg once-daily in the treatment of non-erosive gastroesophageal reflux disease (NERD).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Vonoprazan fumarate, a novel potassium-competitive acid blocker, in the management of gastroesophageal reflux disease: safety and clinical evidence to date.
Sugano K. · · 2018 · cited 109× · PMID 29383028 · DOI 10.1177/1756283x17745776
Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.
Kinoshita Y, Sakurai Y, Takabayashi N, Kudou K, et al · · 2019 · cited 34× · PMID 31770139 · DOI 10.14309/ctg.0000000000000101

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02954848 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 2 August 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02954848.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02954848

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other Takeda trials

Verify against primary sources