Trial · NCT00547703
Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia
NCT00547703, Not applicable, Terminated, The Cleveland Clinic; results first posted 2012-07-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia. Trials, record NCT00547703. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00547703
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Nortriptyline on Abdominal Pain/Discomfort and Quality of Life in Patients With Nonulcer Dyspepsia
- NCT number
- NCT00547703
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 5 participants, actual
- Lead sponsor
- The Cleveland Clinic
- Conditions
- Non Ulcer Dyspepsia
- Interventions
- Nortriptyline, Placebo
- First posted
- 2007-10-23
- Last updated
- 2026-08-25
- Results first posted
- 2012-07-10
- Limitations and caveats
- We were unable to recruit an adequate number of patients to make any meaningful conclusion.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer. | 8 weeks | Patient would answer yes or no to a simple question asking whether they had adequate relief of abdominal pain or discomfort. This was measured at weeks 2,4 and 8 of the study but only week 8 was reported. What is being reported is the number of participants who answered yes. |
| Secondary | Quality Of Life in Reflux and Dyspepsia (QOLRAD) | 8 weeks | Patients were administered the validated QOLRAD (Quality of Life in Reflux and Dyspepsia) questionnaire to assess if nortriptyline improves quality of life in patients with non-ulcer dyspepsia. The total score range is 25 to 175. Higher scores indicate better quality of life. |
| Secondary | Number of Participants With Side Effects | 8 weeks | To assess the number of patients who experienced side effects. Patients were asked about side effects on each office visit and ask to call for significant side effects. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer. | 8 weeks | All patients who completed the 8 weeks of the study | participants | NUMBER |
| SECONDARY | QOLRAD Questionaire for Patients With Upper Abdominal Symptoms | 8 weeks | |||
| SECONDARY | Side Effects | 8 weeks |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer. | Nortriptyline | 2 | participants | ||
| Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer. | Placebo | 1 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nortriptyline | 4 | |
| Overall Study | STARTED | Placebo | 1 | |
| Overall Study | COMPLETED | Nortriptyline | 3 | |
| Overall Study | COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Nortriptyline | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Constipation | Gastrointestinal disorders | Nortriptyline | 2 | 3 | 2 |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 1 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nortriptyline | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Nortriptyline | 2 | 3 |
| Total, other adverse events | Placebo | 1 | 1 |
| Total, serious adverse events | Nortriptyline | 0 | 3 |
| Total, serious adverse events | Placebo | 0 | 1 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Nortriptyline vs Placebo: Question on Whether Patient Has Had Adequate Relief of Abdominal Pain or Discomfort Reported by a Simple Yes or no Answer. | Trial comparisons |
| Nortriptyline 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/NCT00547703
GET https://conductscience.org/api/trials/v1/NCT00547703/registered