Trial · NCT01323582
Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis
NCT01323582, Phase 2, Terminated, University of Florida; results first posted 2014-12-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis. Trials, record NCT01323582. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01323582
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis
- NCT number
- NCT01323582
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Gastroparesis
- Interventions
- Erythromycin, Azithromycin
- First posted
- 2011-03-25
- Last updated
- 2014-12-05
- Results first posted
- 2014-12-05
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time in Minutes for 50% of the Ingested Meal to Empty the Stomach With a Standardized Breath Test: Half the of the Week 11 Value (Period 2) Less Half the of the Week 4 Value (Period 1). This Estimates the Effect Size. | Weeks 4 and 11 (end of periods) | Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to empty 50% (t 1/2) of the accumulated contents is recorded. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies. |
| Primary | Gastroparesis Cardinal Symptom Index (GCSI) Score | Weeks 4 and 11 (end of periods) | This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptoms and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient's symptoms. Reference for GCSI: Revicki DA, REntz AM, Dubois D, et al. Development and validation of a patient-assessed gastroparesis symptoms severity measure: the Gastroparesis Cardinal Symptom Index. Ailment Pharm Ther 2003; 18: 141:50. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies. |
| Secondary | NDI Score | Weeks 4 and 11 (end of periods) | Nepean Dyspepsia Index (NDI) is a measure of symptom status and quality of life in functional dyspepsia. This scale is scored using each subscale (Tension, interference with daily activities), Eating/drinking, Knowledge/control, work/study) and adding up the items for each of the five subscale score (2-10). Total score range would be 10-50). For the NDI, a lower number is better meaning the symptom is not effecting quality of life and a higher score closer to 50 is worse meaning it is effecting patients quality of life. Reference: Talley NJ, Verlinden M, Jones M. Quality of life in functional dyspepsia: responsiveness of the Nepean Dyspepsia Index and developement of a new 10-iten short form. Aliment Pharmacol Ther 2001: 15: 207-216. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies. |
| Secondary | TLAG (Time From Ingestion of Meal to Start of Gastric Emptying) | Weeks 4 and 11 (end of periods) | This is defined as the time from ingestion of the meal to the beginning of the emptying process in minutes. Because the difference is RX-B -RX A in one group and RX A -RX B in the other, the difference between these two estimates twice the effect size. Hence the Half is applied, as is standard in the two sample method for crossover studies. |
| Secondary | Change in Time to 50% Gastric Emptying: Post Test Less Baseline Pooled Over Orderings | Baseline and end of treatment period | Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to reaching 50% of the accumulated contents is recorded. |
| Secondary | Change in Time to 50% Emptying: Post Test Less Baseline Pooled Over Orderings | at baseline before initiation of the treatment and after completion of each treatment period. | Patients will be given a standardized meal enriched with a labeled material and the breath samples are then collected and analyzed. The estimated time to reaching 50% of the accumulated contents is recorded. |
| Secondary | Gastroparesis Cardinal Symptom Index (GCSI) Score Change From Baseline to Post Treatment | Baseline and end of treatment period | This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptom and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient's symptoms are. The scale is reported in the references. The change was calculated by measuring the end of treatment minus baseline GCSI score. Negative value reflects this change. |
| Secondary | Does GCSI Score Improve (Lower) on Treatment, Pooling the AZ Patients Over Their Treatment Periods? Endpoint is Difference in Post-test Less Baseline | Baseline and end of treatment period | This is a Validated instrument for measuring symptom severity in patients with gastroparesis. This scoring is based on a Likert Scale from (0-5) with zero being no symptom and five being very severe symptoms on 9 subscales, making the overall score range from 0-45. The higher the score, the more severe patient's symptoms are. The scale is reported in the references. This is a calculation taken with GCSI score at end of treatment minus baseline. Negative value reflects this change. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time in Minutes for 50% of the Ingested Meal to Empty the Stomach With a Standardized Breath Test: Half the of the Week 11 Value (Period 2) Less Half the of the Week 4 Value (Period 1). This Estimates the Effect Size. | Weeks 4 and 11 (end of periods) | Minutes | MEAN | |
| PRIMARY | Gastroparesis Cardinal Symptom Index (GCSI) Score | Weeks 4 and 11 (end of periods) | One subject did not complete this part of analysis. | units on a scale | MEAN |
| SECONDARY | NDI Score | Weeks 4 and 11 (end of periods) | units on a scale | MEDIAN | |
| SECONDARY | TLAG (Time From Ingestion of Meal to Start of Gastric Emptying) | Weeks 4 and 11 (end of periods) | Minutes | MEAN | |
| SECONDARY | Change in Time to 50% Gastric Emptying: Post Test Less Baseline Pooled Over Orderings | Baseline and end of treatment period | Minutes | MEAN | |
| SECONDARY | Change in Time to 50% Emptying: Post Test Less Baseline Pooled Over Orderings | at baseline before initiation of the treatment and after completion of each treatment period. | minutes | MEAN | |
| SECONDARY | Gastroparesis Cardinal Symptom Index (GCSI) Score Change From Baseline to Post Treatment | Baseline and end of treatment period | One subject did not complete this part of analysis. | units on a scale | MEAN |
| SECONDARY | Does GCSI Score Improve (Lower) on Treatment, Pooling the AZ Patients Over Their Treatment Periods? Endpoint is Difference in Post-test Less Baseline | Baseline and end of treatment period | units on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Time in Minutes for 50% of the Ingested Meal to Empty the Stomach With a Standardized Breath Test: Half the of the Week 11 Value (Period 2) Less Half the of the Week 4 Value (Period 1). This Estimates the Effect Size. | Erythromycin First Then Azithromycin | -1.6 | Standard Deviation 32.3 | Minutes | |
Time in Minutes for 50% of the Ingested Meal to Empty the Stomach With a Standardized Breath Test: Half the of the Week 11 Value (Period 2) Less Half the of the Week 4 Value (Period 1). This Estimates the Effect Size. | Azithromycin Then Erythromycin | -5.2 | Standard Deviation 17.9 | Minutes | |
| Gastroparesis Cardinal Symptom Index (GCSI) Score | Erythromycin First Then Azithromycin | -1.6 | Standard Deviation 5.2 | units on a scale | |
| Gastroparesis Cardinal Symptom Index (GCSI) Score | Azithromycin Then Erythromycin | -2.9 | Standard Deviation 7.0 | units on a scale | |
| NDI Score | Erythromycin First Then Azithromycin | 1.65 | Standard Deviation 5.6 | units on a scale | |
| NDI Score | Azithromycin Then Erythromycin | 1.30 | Standard Deviation 4.60 | units on a scale | |
| TLAG (Time From Ingestion of Meal to Start of Gastric Emptying) | Erythromycin First Then Azithromycin | -1.71 | Standard Deviation 16.2 | Minutes | |
| TLAG (Time From Ingestion of Meal to Start of Gastric Emptying) | Azithromycin Then Erythromycin | -0.22 | Standard Deviation 8.2 | Minutes | |
| Change in Time to 50% Gastric Emptying: Post Test Less Baseline Pooled Over Orderings | Erythromycin | -11.8 | Standard Deviation 40.8 | Minutes | |
| Change in Time to 50% Emptying: Post Test Less Baseline Pooled Over Orderings | Azithromycin | -15.0 | Standard Deviation 31.0 | minutes |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Weeks 1-4 (First Period) | STARTED | Erythromycin First Then Azithromycin | 12 | |
| Weeks 1-4 (First Period) | STARTED | Azithromycin Then Erythromycin | 14 | |
| Weeks 1-4 (First Period) | COMPLETED | Erythromycin First Then Azithromycin | 10 | |
| Weeks 1-4 (First Period) | COMPLETED | Azithromycin Then Erythromycin | 12 | |
| Weeks 1-4 (First Period) | NOT COMPLETED | Erythromycin First Then Azithromycin | 2 | |
| Weeks 1-4 (First Period) | NOT COMPLETED | Azithromycin Then Erythromycin | 2 | |
| Weeks 5-7 (Washout) | STARTED | Erythromycin First Then Azithromycin | 10 | |
| Weeks 5-7 (Washout) | STARTED | Azithromycin Then Erythromycin | 12 | |
| Weeks 5-7 (Washout) | COMPLETED | Erythromycin First Then Azithromycin | 10 | |
| Weeks 5-7 (Washout) | COMPLETED | Azithromycin Then Erythromycin | 11 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events6
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 | abdominal pain | Gastrointestinal disorders | Erythromycin | 1 | 26 | |
| other | abdominal pain | Gastrointestinal disorders | Azithromycin | 3 | 26 | |
| other | nausea | Gastrointestinal disorders | Erythromycin | 0 | 26 | |
| other | nausea | Gastrointestinal disorders | Azithromycin | 3 | 26 | |
| other | vomiting | Gastrointestinal disorders | Erythromycin | 0 | 26 | |
| other | vomiting | Gastrointestinal disorders | Azithromycin | 2 | 26 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Erythromycin | ||
| Total, all-cause mortality | Azithromycin | ||
| Total, other adverse events | Erythromycin | 1 | 26 |
| Total, other adverse events | Azithromycin | 3 | 26 |
| Total, serious adverse events | Erythromycin | 0 | 26 |
| Total, serious adverse events | Azithromycin | 0 | 26 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Erythromycin vs Azithromycin: serious adverse events |
Source 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/NCT01323582
GET https://conductscience.org/api/trials/v1/NCT01323582/registered