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

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ClinicalTrials.gov Identifier: NCT00984815
Recruitment Status : Completed
First Posted : September 25, 2009
Results First Posted : July 25, 2013
Last Update Posted : July 25, 2013
Sponsor:
Information provided by (Responsible Party):
Horizon Pharma Ireland, Ltd., Dublin Ireland

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Osteoarthritis
Rheumatoid Arthritis
Chronic Low Back Pain
Chronic Regional Pain Syndrome
Chronic Soft Tissue Pain
Intervention Drug: HZT-501
Enrollment 86
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.
Arm/Group Title HZT-501
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 86
Completed 56
Not Completed 30
Arm/Group Title HZT-501
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 86
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants
<=18 years
0
   0.0%
Between 18 and 65 years
69
  80.2%
>=65 years
17
  19.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants
56.3  (9.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants
Female
62
  72.1%
Male
24
  27.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 86 participants
86
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events
Hide Description [Not Specified]
Time Frame 54 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled and who received at least one dose of study drug comprised the Safety Population.
Arm/Group Title HZT-501
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 86
Measure Type: Number
Unit of Measure: participants
76
2.Secondary Outcome
Title Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
54 participants who completed the pain intensity questions of the SODA questionnaire at baseline and Week 54.
Arm/Group Title HZT-501
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-3.22  (10.522)
3.Secondary Outcome
Title Change From Baseline in the Non-pain Symptoms Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
55 participants who completed the non-pain symptom questions of the SODA questionnaire at baseline and Week 54.
Arm/Group Title HZT-501
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 55
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-1.44  (3.934)
4.Secondary Outcome
Title Change From Baseline in the Satisfaction With Dyspepsia-Related Health Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
55 participants who completed the satisfaction with dyspepsia-related health questions of the SODA questionnaire at baseline and week 54.
Arm/Group Title HZT-501
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 55
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
2.69  (5.504)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HZT-501
Hide Arm/Group Description 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.
All-Cause Mortality
HZT-501
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HZT-501
Affected / at Risk (%)
Total   9/86 (10.47%) 
Cardiac disorders   
angina unstable  1  1/86 (1.16%) 
Gastrointestinal disorders   
gastric ulcer  1  1/86 (1.16%) 
small intestinal obstruction  1  1/86 (1.16%) 
Infections and infestations   
cellulitis staphylococcal  1  1/86 (1.16%) 
escherichia sepsis  1  1/86 (1.16%) 
pyelonephritis  1  1/86 (1.16%) 
Musculoskeletal and connective tissue disorders   
back pain  1  1/86 (1.16%) 
Nervous system disorders   
convulsion  1  1/86 (1.16%) 
global amnesia  1  1/86 (1.16%) 
Psychiatric disorders   
depression  1  1/86 (1.16%) 
Renal and urinary disorders   
renal failure acute  1  1/86 (1.16%) 
Skin and subcutaneous tissue disorders   
hyperhidrosis  1  1/86 (1.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
HZT-501
Affected / at Risk (%)
Total   76/86 (88.37%) 
Gastrointestinal disorders   
abdominal distension  1  10/86 (11.63%) 
dyspepsia  2  10/86 (11.63%) 
flatulence  2  9/86 (10.47%) 
diarrhoea  2  8/86 (9.30%) 
nausea  2  8/86 (9.30%) 
abdominal pain lower  2  4/86 (4.65%) 
constipation  2  4/86 (4.65%) 
gastroesophageal reflux disease  2  4/86 (4.65%) 
abdominal pain  2  3/86 (3.49%) 
abdominal pain upper  2  3/86 (3.49%) 
vomiting  2  3/86 (3.49%) 
oedema peripheral  2  4/86 (4.65%) 
General disorders   
pitting oedema  2  3/86 (3.49%) 
Infections and infestations   
sinusitis  2  9/86 (10.47%) 
urinary tract infection  2  8/86 (9.30%) 
gastroenteritis viral  2  7/86 (8.14%) 
upper respiratory tract infection  2  7/86 (8.14%) 
influenza  2  4/86 (4.65%) 
herpes zoster  2  3/86 (3.49%) 
Injury, poisoning and procedural complications   
excoriation  2  5/86 (5.81%) 
muscle strain  2  4/86 (4.65%) 
procedural pain  2  4/86 (4.65%) 
Musculoskeletal and connective tissue disorders   
arthralgia  2  5/86 (5.81%) 
back pain  2  4/86 (4.65%) 
osteoarthritis  2  4/86 (4.65%) 
Nervous system disorders   
headache  2  3/86 (3.49%) 
Psychiatric disorders   
depression  2  3/86 (3.49%) 
Respiratory, thoracic and mediastinal disorders   
sinus congestion  2  4/86 (4.65%) 
Skin and subcutaneous tissue disorders   
dermatitis contact  2  3/86 (3.49%) 
rash  2  3/86 (3.49%) 
Vascular disorders   
hypertension  2  8/86 (9.30%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
2
Term from vocabulary, MedDRA (9.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Amy Y. Grahn, MS
Organization: Horizon Pharma
Phone: 224-383-3012
Responsible Party: Horizon Pharma Ireland, Ltd., Dublin Ireland
ClinicalTrials.gov Identifier: NCT00984815     History of Changes
Other Study ID Numbers: HZ-CA-401
First Submitted: September 23, 2009
First Posted: September 25, 2009
Results First Submitted: March 18, 2013
Results First Posted: July 25, 2013
Last Update Posted: July 25, 2013