Trial Outcomes & Findings for Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment (NCT NCT00984815)

NCT ID: NCT00984815

Last Updated: 2024-12-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 86 participants
• Primary outcome timeframe: 54 weeks
• Results posted on: 2024-12-18

Participant Flow

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.

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.

Participant milestones

Measure	HZT-501 Open-label treatment with HZT-501(ibuprofen 800 mg/famotidine 26.6 mg) tablets. All doses of study drug will be self-administered orally 3 times daily (TID), for up to 54 weeks.
Overall Study STARTED	86
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	HZT-501 n=86 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	69 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age, Continuous	56.3 years STANDARD_DEVIATION 9.39 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment United States	86 participants n=5 Participants

PRIMARY outcome

Timeframe: 54 weeks

Population: All participants enrolled and who received at least one dose of study drug comprised the Safety Population.

Outcome measures

Measure	HZT-501 n=86 Participants 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.
Number of Participants With Treatment Emergent Adverse Events	76 participants

SECONDARY outcome

Timeframe: Baseline and 54 Weeks

Population: 54 participants who completed the pain intensity questions of the SODA questionnaire at baseline and Week 54.

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.

Outcome measures

Measure	HZT-501 n=54 Participants 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.
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 outcome

Timeframe: Baseline and 54 Weeks

Population: 55 participants who completed the non-pain symptom questions of the SODA questionnaire at baseline and Week 54.

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.

Outcome measures

Measure	HZT-501 n=55 Participants 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.
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 outcome

Timeframe: 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.

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.

Outcome measures

Measure	HZT-501 n=55 Participants 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.
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

Adverse Events

HZT-501

Serious events: 9 serious events

Other events: 76 other events

Deaths: 0 deaths

Serious adverse events

Measure	HZT-501 n=86 participants at risk 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.
Cardiac disorders angina unstable	1.2% 1/86
Gastrointestinal disorders gastric ulcer	1.2% 1/86
Gastrointestinal disorders small intestinal obstruction	1.2% 1/86
Infections and infestations cellulitis staphylococcal	1.2% 1/86
Infections and infestations escherichia sepsis	1.2% 1/86
Infections and infestations pyelonephritis	1.2% 1/86
Musculoskeletal and connective tissue disorders back pain	1.2% 1/86
Nervous system disorders convulsion	1.2% 1/86
Nervous system disorders global amnesia	1.2% 1/86
Psychiatric disorders depression	1.2% 1/86
Renal and urinary disorders renal failure acute	1.2% 1/86
Skin and subcutaneous tissue disorders hyperhidrosis	1.2% 1/86

Other adverse events

Measure	HZT-501 n=86 participants at risk 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.
Gastrointestinal disorders abdominal distension	11.6% 10/86
Gastrointestinal disorders dyspepsia	11.6% 10/86
Gastrointestinal disorders flatulence	10.5% 9/86
Gastrointestinal disorders diarrhoea	9.3% 8/86
Gastrointestinal disorders nausea	9.3% 8/86
Gastrointestinal disorders abdominal pain lower	4.7% 4/86
Gastrointestinal disorders constipation	4.7% 4/86
Gastrointestinal disorders gastroesophageal reflux disease	4.7% 4/86
Gastrointestinal disorders abdominal pain	3.5% 3/86
Gastrointestinal disorders abdominal pain upper	3.5% 3/86
Gastrointestinal disorders vomiting	3.5% 3/86
Gastrointestinal disorders oedema peripheral	4.7% 4/86
General disorders pitting oedema	3.5% 3/86
Infections and infestations sinusitis	10.5% 9/86
Infections and infestations urinary tract infection	9.3% 8/86
Infections and infestations gastroenteritis viral	8.1% 7/86
Infections and infestations upper respiratory tract infection	8.1% 7/86
Infections and infestations influenza	4.7% 4/86
Infections and infestations herpes zoster	3.5% 3/86
Injury, poisoning and procedural complications excoriation	5.8% 5/86
Injury, poisoning and procedural complications muscle strain	4.7% 4/86
Injury, poisoning and procedural complications procedural pain	4.7% 4/86
Musculoskeletal and connective tissue disorders arthralgia	5.8% 5/86
Musculoskeletal and connective tissue disorders back pain	4.7% 4/86
Musculoskeletal and connective tissue disorders osteoarthritis	4.7% 4/86
Nervous system disorders headache	3.5% 3/86
Psychiatric disorders depression	3.5% 3/86
Respiratory, thoracic and mediastinal disorders sinus congestion	4.7% 4/86
Skin and subcutaneous tissue disorders dermatitis contact	3.5% 3/86
Skin and subcutaneous tissue disorders rash	3.5% 3/86
Vascular disorders hypertension	9.3% 8/86

Additional Information

Amy Y. Grahn, MS

Horizon Pharma

Phone: 224-383-3012

Email: agrahn@horizonpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee PI may disclose data resulting from the study upon the earliest of: a) publication of a multi-center publication coordinated by Sponsor, b) submission of the data by Sponsor to the FDA, and c) 18 months after the study is completed at all sites if a multi-center publication is not submitted by Sponsor for publication provided PI submits proposed publication at least 60 days in advance for review of any Sponsor Confidential Information.
• Publication restrictions are in place

Restriction type: OTHER