Trial · NCT02954848
Phase 3 Study of TAK-438 10 mg in the Treatment of Non-Erosive Gastroesophageal Reflux Disease (NERD)
NCT02954848, Phase 3, Completed, Takeda; results first posted 2019-08-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Study of TAK-438 10 mg in the Treatment of Non-Erosive Gastroesophageal Reflux Disease (NERD). Trials, record NCT02954848. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02954848
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study of TAK-438 10 mg in the Treatment of Non-Erosive Gastroesophageal Reflux Disease (NERD)
- NCT number
- NCT02954848
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 484 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Non-erosive Gastroesophageal Reflux Disease
- Interventions
- Placebo, TAK-438 10 mg
- First posted
- 2016-11-04
- Last updated
- 2019-08-02
- Results first posted
- 2019-08-02
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Days Without Symptoms of Heartburn | 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. |
| Primary | Cumulative Rate of Improvement in Symptoms of Heartburn | 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 between Day 0 and Day 24 and is reported for the following time points: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24. Data not collected were shown as NA = Not Applicable. |
| Primary | Severity of Symptoms of Heartburn | 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, with the higher scores reflecting the greater severity. The severity of heartburn was calculated by the number of severity score in daily diaries. |
| Secondary | Percentage of Days Without Symptoms of Heartburn in Subgroup Stratified by Response (Improved or Not Improved) at Week 2 | 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 period up to Week 2 \[Day 14\] was lower than that during the run-in period; Not improved: the proportion of days the participants experienced heartburn during the treatment period up to Week 2 \[Day 14\] was equal to or larger than that during the run-in period. |
| Secondary | Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Response (Improved Per Criteria 1) at Week 2 | 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 experienced heartburn on 2 days or more of the 7 days prior to Week 2 \[Day 8 through Day 14\]. Cumulative data was collected between Day 0 and Day 22 and is reported for following time points: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 11, 15, 16, 17, 18, 19, 20, 21, and 22. Data not collected were shown as NA = Not Applicable. |
| Secondary | Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Response (Not Improved Per Criteria 1) at Week 2 | 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 experienced heartburn on 2 days or more of the 7 days prior to Week 2 \[Day 8 through Day 14\]. Cumulative data was collected between Day 0 and Day 24 and is reported for following time points: Days 0, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24. Data not collected were shown as NA = Not Applicable. |
| Secondary | Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Response (Improved Per Criteria 2) at Week 2 | 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: proportion of days participants experienced heartburn during treatment period up to Week 2 \[Day 14\] was equal to or larger than that during the run-in period. Cumulative data was collected between Day 0 and Day 24 and is reported for following time points: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24. Data not collected were shown as NA=Not Applicable. |
| Secondary | Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Response (Not Improved Per Criteria 2) at Week 2 | 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: proportion of days participants experienced heartburn during treatment period up to Week 2 \[Day 14\] was equal to or larger than that during run-in period. Cumulative data was collected between Day 0 and Day 24 and is reported for following time points: Days 0, 5, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24. Data not collected shown as NA=Not Applicable. |
| Secondary | Severity of Symptoms of Heartburn in Subgroup Stratified by Response (Improved or Not Improved) at Week 2 | 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 prior to Week 2 \[Day 8 through Day 14\] and Criteria 2, i.e. Improved: proportion of days the participants experienced heartburn during the treatment period up to Week 2 \[Day 14\] was lower than that during the run-in period; Not improved: proportion of days the participants experienced heartburn during the treatment period up to Week 2 \[Day 14\] was equal to or larger than that during the run-in period. |
| Secondary | Percentage of Days Without Symptoms of Heartburn in Subgroup Stratified by Endoscopic Findings (the Modified LA Classification Grade N or M) at Baseline | 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-confluent mucosal breaks ≥5mm in length; Grade C: confluent mucosal breaks \<75% circumferential; Grade D: confluent mucosal breaks \>75% circumferential. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Days Without Symptoms of Heartburn | Up to Week 4 | Full analysis set (FAS) included participants who were randomized and received at least one dose of the study drug. | percentage of days | MEDIAN |
| PRIMARY | Cumulative Rate of Improvement in Symptoms of Heartburn | Day 0 to Day 24 | FAS included participants who were randomized and received at least one dose of the study drug. | percentage of participants | NUMBER |
| PRIMARY | Severity of Symptoms of Heartburn | Up to Week 4 | FAS included participants who were randomized and received at least one dose of the study drug. | score on a scale | MEDIAN |
| SECONDARY | Percentage of Days Without Symptoms of Heartburn in Subgroup Stratified by Response (Improved or Not Improved) at Week 2 | Up to Week 4 | FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable at each category. | percentage of days | MEDIAN |
| SECONDARY | Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Response (Improved Per Criteria 1) at Week 2 | Day 0 to Day 22 | FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable at each category. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Response (Not Improved Per Criteria 1) at Week 2 | Day 0 to Day 24 | FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable at each category. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Response (Improved Per Criteria 2) at Week 2 | Day 0 to Day 24 | FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable at each category. | percentage of participants | NUMBER |
| SECONDARY | Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Response (Not Improved Per Criteria 2) at Week 2 | Day 0 to Day 24 | FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable at each category. | percentage of participants | NUMBER |
| SECONDARY | Severity of Symptoms of Heartburn in Subgroup Stratified by Response (Improved or Not Improved) at Week 2 | Up to Week 4 | FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable at each category. | score on a scale | MEDIAN |
| SECONDARY | Percentage of Days Without Symptoms of Heartburn in Subgroup Stratified by Endoscopic Findings (the Modified LA Classification Grade N or M) at Baseline | Up to Week 4 | FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who had endoscopic findings. | percentage of days | MEDIAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group702
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Days Without Symptoms of Heartburn | Placebo | 61.50 | Full Range 0.0 to 100.0 | percentage of days | |
| Percentage of Days Without Symptoms of Heartburn | TAK-438 10 mg | 72.55 | Full Range 0.0 to 100.0 | percentage of days | |
| Cumulative Rate of Improvement in Symptoms of Heartburn | Placebo | Day 0 | 0.0 | percentage of participants | |
| Cumulative Rate of Improvement in Symptoms of Heartburn | TAK-438 10 mg | Day 0 | 0.0 | percentage of participants | |
| Cumulative Rate of Improvement in Symptoms of Heartburn | Placebo | Day 1 | 14.7 | percentage of participants | |
| Cumulative Rate of Improvement in Symptoms of Heartburn | TAK-438 10 mg | Day 1 | 23.1 | percentage of participants | |
| Cumulative Rate of Improvement in Symptoms of Heartburn | Placebo | Day 2 | 15.9 | percentage of participants | |
| Cumulative Rate of Improvement in Symptoms of Heartburn | TAK-438 10 mg | Day 2 | 24.4 | percentage of participants | |
| Cumulative Rate of Improvement in Symptoms of Heartburn | Placebo | Day 3 | 16.3 | percentage of participants | |
| Cumulative Rate of Improvement in Symptoms of Heartburn | TAK-438 10 mg | Day 3 | 25.2 | percentage of participants |
1 to 10 of 702Source ClinicalTrials.gov
See all 702 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 245 | |
| Overall Study | STARTED | TAK-438 10 mg | 239 | |
| Overall Study | Treated | Placebo | 245 | |
| Overall Study | Treated | TAK-438 10 mg | 238 | |
| Overall Study | COMPLETED | Placebo | 243 | |
| Overall Study | COMPLETED | TAK-438 10 mg | 234 | |
| Overall Study | NOT COMPLETED | Placebo | 2 | |
| Overall Study | NOT COMPLETED | TAK-438 10 mg | 5 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Viral upper respiratory tract infection | Infections and infestations | Placebo | 12 | 245 | |
| other | Viral upper respiratory tract infection | Infections and infestations | TAK-438 10 mg | 10 | 238 | |
| serious | Colitis ulcerative | Gastrointestinal disorders | Placebo | 1 | 245 | |
| serious | Colitis ulcerative | Gastrointestinal disorders | TAK-438 10 mg | 0 | 238 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 245 |
| Total, all-cause mortality | TAK-438 10 mg | 0 | 238 |
| Total, other adverse events | Placebo | 12 | 245 |
| Total, other adverse events | TAK-438 10 mg | 10 | 238 |
| Total, serious adverse events | Placebo | 1 | 245 |
| Total, serious adverse events | TAK-438 10 mg | 0 | 238 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31770139 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TAK-438 10 mg vs Placebo: deaths from any cause | Trial comparisons |
| TAK-438 10 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02954848
GET https://conductscience.org/api/trials/v1/NCT02954848/registered?page=2