Chronic Low Back Pain, Chronic Regional Pain Syndrome, Chronic Soft Tissue Pain, Osteoarthritis, Rheumatoid Arthritis
Conditions
Keywords
NSAID, Chronic Pain, Osteoarthritis, Rheumatoid Arthritis
Brief summary
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients that require long-term NSAID treatment.
Detailed description
HZT-501, a fixed-dose combination of ibuprofen, a pain and inflammation relieving non-steroidal anti-inflammatory drug (NSAID), and famotidine, a histamine type 2 receptor antagonist (H2RA), is being developed for the treatment of patients with signs and symptoms of osteoarthritis, rheumatoid arthritis, mild to moderate pain or dysmenorrhea who are at risk of developing ibuprofen-associated upper gastrointestinal ulcers. Study with completed results acquired from Horizon in 2024.
Interventions
DRUGHZT-501
Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day
Sponsors
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient is capable of understanding the purpose and risks of the study and is able to provide written Informed Consent. * Patient is male or female, aged 40 to 80 years of age. * Patient is expected to require daily administration of an NSAID for at least the coming year for conditions including but not limited to: osteoarthritis, rheumatoid arthritis, chronic low back pain, chronic regional pain syndrome, chronic soft tissue pain. * Female patients of childbearing potential and male patients with partners of childbearing potential must agree to use medically acceptable methods of contraception throughout the entire study period. * Patient is willing and able to comply with the prescribed treatment protocol and evaluations.
Exclusion criteria
* Patient has a history of or experienced any of the following: * NSAID-associated and/or primary peptic ulcer disease-associated serious gastrointestinal complications such as perforation of ulcers, gastric outlet obstruction due to ulcers, and/or acute gastrointestinal bleeding * NSAID-induced asthma exacerbation, acute renal failure, interstitial nephritis, and/or hepatitis * Malignant disease of the gastrointestinal tract * Erosive esophagitis * Coronary artery bypass graft (CABG) surgery within the 14 days prior to study Day 0 * Uncontrolled diabetes mellitus as evidenced by Hemoglobin A1c \> 7% * Known history of human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C * Patient has active cardiac, renal, and/or hepatic disease, as evidenced by: * Creatinine clearance \< 45 mL/min (based on the Cockroft-Gault formula) at Screening * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 2.5 times the upper limit of normal at Screening * History of acute myocardial infarction, unstable cardiac arrhythmias, and/or stroke within the 6 months prior to study entry * Uncontrolled congestive heart failure * Uncontrolled hypertension * Patient currently is participating in an investigational drug study, or patient participated in an investigational drug study within the 30 days prior to study entry. * Female patient has a positive urine pregnancy test at Screening and/or Study Day 0. * Patient has a concomitant disease or condition that, in the opinion of the Investigator, could interfere with the conduct of the study or could put the patient at unacceptable risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment Emergent Adverse Events | 54 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Up to 100 eligible participants were to be enrolled at 4 U.S. study centers (3 private practice rheumatology centers and 1 academic center) between September, 2009 and June, 2010.
Pre-assignment details
Eligible participants, 40-80 years of age inclusive, expected to require daily administration of a non-steroidal anti-inflammatory drug (NSAID) for at least the coming 12 months were enrolled. Of the approximately 100 participants enrolled, it was expected that at least 30 would complete the 54-week treatment period.
Participants by arm
| Arm | Count |
|---|---|
| HZT-501 Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks. | 86 |
| Total | 86 |
Baseline characteristics
| Characteristic | HZT-501 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 69 Participants |
| Age, Continuous | 56.3 years STANDARD_DEVIATION 9.39 |
| Region of Enrollment United States | 86 participants |
| Sex: Female, Male Female | 62 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 76 / 86 |
| serious Total, serious adverse events | 9 / 86 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events
Time frame: 54 weeks
Population: All participants enrolled and who received at least one dose of study drug comprised the Safety Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HZT-501 | Number of Participants With Treatment Emergent Adverse Events | 76 participants |
Secondary
Change From Baseline in the Non-pain Symptoms Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 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.
Time frame: Baseline and 54 Weeks
Population: 55 participants who completed the non-pain symptom questions of the SODA questionnaire at baseline and Week 54.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HZT-501 | Change From Baseline in the Non-pain Symptoms Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks | -1.44 Scores on a scale | Standard Deviation 3.934 |
Secondary
Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 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.
Time frame: Baseline and 54 Weeks
Population: 54 participants who completed the pain intensity questions of the SODA questionnaire at baseline and Week 54.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HZT-501 | Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks | -3.22 Scores on a scale | Standard Deviation 10.522 |
Secondary
Change From Baseline in the Satisfaction With Dyspepsia-Related Health Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 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.
Time frame: Baseline and 54 Weeks
Population: 55 participants who completed the satisfaction with dyspepsia-related health questions of the SODA questionnaire at baseline and week 54.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HZT-501 | Change From Baseline in the Satisfaction With Dyspepsia-Related Health Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks | 2.69 Scores on a scale | Standard Deviation 5.504 |