Trial Outcomes & Findings for Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study (NCT NCT00486031)

NCT ID: NCT00486031

Last Updated: 2019-08-15

Results Overview

Incidence of treatment emergent adverse events

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 443 participants
• Primary outcome timeframe: 24 Months
• Results posted on: 2019-08-15

Participant Flow

Participant milestones

Measure	Balsalazide Disodium Tabs,3.3 g BID Balsalazide Disodium tablets,3.3 g BID
Overall Study STARTED	443
Overall Study COMPLETED	440
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study

Baseline characteristics by cohort

Measure	Balsalazide Disodium Tabs,3.3 g BID, n=440 Participants balsalazide disodium tablets,3.3 g BID,
Age, Customized <65 years	412 Participants n=5 Participants
Age, Customized >=65 years	28 Participants n=5 Participants
Sex: Female, Male Female	216 Participants n=5 Participants
Sex: Female, Male Male	224 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 Months

Incidence of treatment emergent adverse events

Outcome measures

Measure	Balsalazide Disodium n=440 Participants balsalazide disodium tablets,3.3 g BID,
Incidence of Treatment Emergent AEs	273 participants

SECONDARY outcome

Timeframe: 24 Months

Population: Data were not collected to perform this analysis

Time to onset of adverse events

Outcome measures

Outcome data not reported

Adverse Events

Balsalazide Disodium

Serious events: 21 serious events

Other events: 273 other events

Deaths: 0 deaths

Serious adverse events

Measure	Balsalazide Disodium n=440 participants at risk balsalazide disodium tablets,3.3 g BID,
Gastrointestinal disorders Colitis ulcerative	1.1% 5/440
Blood and lymphatic system disorders ANAEMIA	0.23% 1/440
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.23% 1/440
Cardiac disorders CHEST PAIN	0.23% 1/440
Cardiac disorders VENTRICULAR DYSFUNCTION	0.23% 1/440
Gastrointestinal disorders ABDOMINAL PAIN	0.45% 2/440
Infections and infestations APPENDICITIS	0.23% 1/440
Infections and infestations Bronchitis	0.23% 1/440
Infections and infestations Cellulitis	0.45% 2/440
Infections and infestations CLOSTRIDIAL INFECTION	0.23% 1/440
Infections and infestations CLOSTRIDIUM COLITIS	0.23% 1/440
Infections and infestations INFLUENZA	0.23% 1/440
Infections and infestations PNEUMONIA	0.23% 1/440
Injury, poisoning and procedural complications LOWER LIMB FRACTURE	0.23% 1/440
Investigations PANCREATIC ENZYMES INCREASED	0.23% 1/440
Investigations WEIGHT DECREASED	0.23% 1/440

Other adverse events

Measure	Balsalazide Disodium n=440 participants at risk balsalazide disodium tablets,3.3 g BID,
Gastrointestinal disorders Worsening UC	10.9% 48/440
Gastrointestinal disorders Diarrhea	6.1% 27/440
Gastrointestinal disorders Abdominal pain	5.9% 26/440
Gastrointestinal disorders Rectal haemorrhage	4.5% 20/440
Gastrointestinal disorders Nausea	3.0% 13/440
Gastrointestinal disorders Abdominal tenderness	2.0% 9/440
Gastrointestinal disorders Constipation	1.8% 8/440
Gastrointestinal disorders Dyspepsia	1.8% 8/440
Gastrointestinal disorders Hematochezia	1.6% 7/440
Gastrointestinal disorders Hemorrhoids	1.6% 7/440
Infections and infestations Urinary tract infection	4.8% 21/440
Infections and infestations Nasopharyngitis	4.3% 19/440
Infections and infestations Upper respiratory tract infection	4.3% 19/440
Infections and infestations Sinusitis	3.4% 15/440
Infections and infestations Influenza	3.0% 13/440
Infections and infestations Bronchitis	1.8% 8/440
Musculoskeletal and connective tissue disorders Arthralgia	4.3% 19/440
Musculoskeletal and connective tissue disorders Back Pain	1.8% 8/440
Nervous system disorders Headache	5.5% 24/440
Nervous system disorders Dizziness	1.8% 8/440
Product Issues Insomnia	1.8% 8/440
Psychiatric disorders Depression	1.6% 7/440
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	1.6% 7/440
Respiratory, thoracic and mediastinal disorders Rash	2.5% 11/440

Additional Information

Johnson Varughese

Valeant Pharmaceuticals

Phone: 9089271400

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place