Clinical trial NCT02311881: A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients With Osteoarthritis
Official title: An Efficacy and Safety Study of Sustained-release Paracetamol in Subjects With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-12-09
Enrollment: 960
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether paracetamol 1000 mg sustained-release (SR) tablets administered orally, twice daily are effective and safe in the treatment of patients with osteoarthritis of the knee or hip.


Eligibility criteria: Inclusion Criteria:

* Male or female participants between 40 and 80 years of age
* Diagnosis of moderate to moderately-severe osteoarthritis (OA) of either the knee or hip with respect to the following:

  * Pain in one knee/hip over 3 months immediately before screening visit
  * Use of non steroidal anti-inflammatory drugs (NSAIDs), acetaminophen (paracetamol) or any other analgesic for 3 or more days per week for at least 3 months prior to screening visit
  * Clinical diagnosis of osteoarthritis of knee/hip for minimum 6 month duration prior to screening visit
  * Therapeutic benefit with acetaminophen use with a score of ≥ 1 on 5-point categorical scale
  * Radiological evidence of ≥ Grade 2 osteoarthritis according to Kellgren-Lawrence radiographic criteria
* Increased WOMAC Pain Subscale score of at least 20 % following untreated run-in period
* Moderate to moderately-severe self-reported pain on a 5-point categorical scale following untreated run-in period
* Historical self-reported positive therapeutic benefit with paracetamol use for osteoarthritis pain relief

Exclusion Criteria:

* History of surgery or major trauma to the study joint
* Clinically significant signs or symptoms of inflammation upon completion of run-in period
* Required ongoing use of analgesic therapy for other indications, anticoagulants, psychotherapeutic agents, aspirin at daily doses greater than 325 mg, statin-class hypolipidemic agents at doses that have not been stabilized, or other treatments know to interfere with pain perception
* History of hepatic or renal or liver or biliary disease or gastrointestinal surgery
* Participants with alanine aminotransferase (ALT) \>2 times Upper Limit Normal (2xULN) and bilirubin \> 1.5 times Upper Limit Normal (1.5xULN) (However, if direct bilirubin is \<35% and fractioned, isolated bilirubin \>1.5xULN is acceptable)
* Other arthritis type, fibromyalgia or collagen vascular disease or secondary OA of study joint or chronic pain condition

Primary outcomes:
measure: Time-weighted Mean Change From Baseline in Western Ontario McMaster (WOMAC) Pain Through Week 12 of Treatment
timeFrame: Baseline up to week 12
Secondary outcomes:
measure: Time Weighted Mean Change From Baseline in WOMAC Physical Function Through Week 12 of Treatment
timeFrame: Baseline up to Week 12
measure: Time Weighted Mean Change From Baseline in WOMAC Stiffness Through Week 12 of Treatment
timeFrame: Baseline up to week 12
measure: Time-weighted Mean Change From Baseline in WOMAC Total Index Through Week 12 of Treatment
timeFrame: Baseline up to week 12
measure: Mean Change From Baseline in Global Patient Assessment of Arthritis (GPAOA)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Number of Participants Classified as Responder
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline in Daily Pain, Daily Stiffness and Pain/Stiffness (Composite) at Week 12
timeFrame: Baseline, Week 12
measure: Mean Number of Rescue Medication Pills Taken Per Day up to 12 Weeks
timeFrame: every day up to 12 weeks
measure: Mean Change From Baseline in Chronic Pain Sleep Inventory (CPSI)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Patient Global Assessment of Response to Therapy (PGART)
timeFrame: Week 4, Week 8, Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: GSK Investigational Site
state: Alabama
city: Chandler
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: Carmichael
country: United States
facility: GSK Investigational Site
state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: North Hollywood
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Brandon
country: United States
facility: GSK Investigational Site
state: Florida
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: Edgewater
country: United States
facility: GSK Investigational Site
state: Florida
city: Hialeah
country: United States
facility: GSK Investigational Site
state: Florida
city: Hialeah
country: United States
facility: GSK Investigational Site
state: Florida
city: Homestead
country: United States
facility: GSK Investigational Site
state: Florida
city: Jupiter
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Oldsmar
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Oviedo
country: United States
facility: GSK Investigational Site
state: Florida
city: Port Orange
country: United States
facility: GSK Investigational Site
state: Florida
city: South Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Savannah
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Evanston
country: United States
facility: GSK Investigational Site
state: Illinois
city: Prairie Village
country: United States
facility: GSK Investigational Site
state: Kansas
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Crestview Hills
country: United States
facility: GSK Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Watertown
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Bellevue
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Brooklyn
country: United States
facility: GSK Investigational Site
state: New York
city: Buffalo
country: United States
facility: GSK Investigational Site
state: New York
city: Hartsdale
country: United States
facility: GSK Investigational Site
state: New York
city: Hickory
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dayton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Toledo
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Altoona
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Duncansville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Smithfield
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Plano
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: