Trial · NCT00984815

Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment

NCT00984815, Phase 3, Completed, Amgen; results first posted 2013-07-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment. Trials, record NCT00984815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00984815

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment
NCT number: NCT00984815
Status: Completed
Phases: Phase 3
Enrollment: 86 participants, actual
Lead sponsor: Amgen
Conditions: Osteoarthritis, Rheumatoid Arthritis, Chronic Low Back Pain, Chronic Regional Pain Syndrome, Chronic Soft Tissue Pain
Interventions: HZT-501
First posted: 2009-09-25
Last updated: 2024-12-18
Results first posted: 2013-07-25

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment Emergent Adverse Events	54 weeks
Secondary	Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks	Baseline and 54 Weeks	The pain intensity scale of the SODA questionnaire ranges from 2 - 47. Change from baseline compares the score at Week 54 to the baseline score for each participant who completed the pain intensity questions of the SODA questionnaire at baseline and Week 54. Higher scores indicate greater symptom severity and therefore a negative mean change from baseline is indicative of an improvement in symptoms.
Secondary	Change From Baseline in the Non-pain Symptoms Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks	Baseline and 54 Weeks	The non-pain symptom scale of the SODA questionnaire ranges from 7 - 35. Change from baseline compares the score at Week 54 to the baseline score for each participant that completed the non-pain symptom questions of the SODA questionnaire at baseline and Week 54. Higher scores indicate greater symptom severity and therefore a negative mean change from baseline is indicative of an improvement in symptoms.
Secondary	Change From Baseline in the Satisfaction With Dyspepsia-Related Health Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks	Baseline and 54 Weeks	The satisfaction with dyspepsia-related health scale of the SODA questionnaire ranges from 2 - 23. Change from baseline compares the score at Week 54 to the baseline score for each participant who completed the Satisfaction questions of the SODA questionnaire at baseline and Week 54. A positive change from baseline in the SODA satisfaction scale represents a participant's overall improved satisfaction with their dyspepsia-related health.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks	Baseline and 54 Weeks	54 participants who completed the pain intensity questions of the SODA questionnaire at baseline and Week 54.	Scores on a scale	MEAN
PRIMARY	Number of Participants With Treatment Emergent Adverse Events	54 weeks	All participants enrolled and who received at least one dose of study drug comprised the Safety Population.	participants	NUMBER
SECONDARY	Change From Baseline in the Non-pain Symptoms Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks	Baseline and 54 Weeks	55 participants who completed the non-pain symptom questions of the SODA questionnaire at baseline and Week 54.	Scores on a scale	MEAN
SECONDARY	Change From Baseline in the Satisfaction With Dyspepsia-Related Health Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks	Baseline and 54 Weeks	55 participants who completed the satisfaction with dyspepsia-related health questions of the SODA questionnaire at baseline and week 54.	Scores on a scale	MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks	HZT-501	-3.22	Standard Deviation 10.522	Scores on a scale
Number of Participants With Treatment Emergent Adverse Events	HZT-501	76		participants
Change From Baseline in the Non-pain Symptoms Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks	HZT-501	-1.44	Standard Deviation 3.934	Scores on a scale
Change From Baseline in the Satisfaction With Dyspepsia-Related Health Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks	HZT-501	2.69	Standard Deviation 5.504	Scores on a scale

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	HZT-501	86
Overall Study	COMPLETED	HZT-501	56
Overall Study	NOT COMPLETED	HZT-501	30

Source ClinicalTrials.gov

Adverse events43

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
other	abdominal distension	Gastrointestinal disorders	HZT-501	10	86
other	dyspepsia	Gastrointestinal disorders	HZT-501	10	86
other	flatulence	Gastrointestinal disorders	HZT-501	9	86
other	diarrhoea	Gastrointestinal disorders	HZT-501	8	86
other	nausea	Gastrointestinal disorders	HZT-501	8	86
other	abdominal pain lower	Gastrointestinal disorders	HZT-501	4	86
other	constipation	Gastrointestinal disorders	HZT-501	4	86
other	gastroesophageal reflux disease	Gastrointestinal disorders	HZT-501	4	86
other	abdominal pain	Gastrointestinal disorders	HZT-501	3	86
other	abdominal pain upper	Gastrointestinal disorders	HZT-501	3	86

1 to 10 of 43Source ClinicalTrials.gov

See all 43 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	HZT-501
Total, other adverse events	HZT-501	76	86
Total, serious adverse events	HZT-501	9	86

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25495134	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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00984815

GET https://conductscience.org/api/trials/v1/NCT00984815/events?page=2

API reference For AI assistants