Last updated: 11/03/2018 22:19:06
A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients with Osteoarthritis
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An Efficacy and Safety Study of Sustained-release Paracetamol in Subjects with Osteoarthritis
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
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:
Time weighted mean change from baseline in WOMAC Physical function through week 12 of treatment
Timeframe: Baseline up to Week 12
Time weighted mean change from baseline in WOMAC stiffness through week 12 of treatment
Timeframe: Baseline up to week 12
Time-weighted mean change from baseline in WOMAC total index through week 12 of treatment
Timeframe: Baseline up to week 12
Mean change from baseline in Global Patient Assessment of Arthritis (GPAOA)
Timeframe: Baseline, Week 4, Week 8, Week 12
Number of participants classified as Responder
Timeframe: Baseline, Week 12
Mean change from baseline in Daily Pain, Daily Stiffness and Pain/Stiffness (composite) at Week 12
Timeframe: Baseline, Week 12
Mean Number of Rescue Medication Pills Taken per day up to 12 weeks
Timeframe: every day up to 12 weeks
Mean change from baseline in Chronic Pain Sleep Inventory (CPSI)
Timeframe: Baseline, Week 4, Week 8, Week 12
Patient Global Assessment of Response to Therapy (PGART)
Timeframe: Week 4, Week 8, Week 12
Interventions:
Drug: Paracetamol 1000 mg SR tablets
Drug: Paracetamol 665 mg SR tablets
Drug: Placebo
Enrollment:
960
Observational study model:
Not applicable
Primary completion date:
2016-16-02
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pain
Product
paracetamol
Collaborators
Not applicable
Study date(s)
January 2015 to February 2016
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
40 - 80 years
Accepts healthy volunteers
No
- 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:
- History of surgery or major trauma to the study joint
- Clinically significant signs or symptoms of inflammation upon completion of run-in period
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female participants between 40 and 80 years of age
- 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
Diagnosis of moderate to moderately-severe osteoarthritis (OA) of either the knee or hip with respect to the following:
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
Trial location(s)
Location
GSK Investigational Site
Edgewater, Florida, United States, 32132
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92801
Status
Study Complete
Location
GSK Investigational Site
Huntsville, Alabama, United States, 35801
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Jupiter, Florida, United States, 33458
Status
Study Complete
Location
GSK Investigational Site
Smithfield, Pennsylvania, United States, 15478
Status
Study Complete
Location
GSK Investigational Site
Dallas, Texas, United States, 75230
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Altoona, Pennsylvania, United States, 16602
Status
Study Complete
Location
GSK Investigational Site
North Hollywood, California, United States, 91606-1559
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35242
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93702
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33756
Status
Study Complete
Location
GSK Investigational Site
Evanston, Illinois, United States, 60201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hickory, North Carolina, United States, 28601
Status
Study Complete
Location
GSK Investigational Site
Hialeah, Florida, United States, 33016
Status
Study Complete
Location
GSK Investigational Site
Homestead, Florida, United States, 33030
Status
Study Complete
Location
GSK Investigational Site
Watertown, Massachusetts, United States, 02472
Status
Study Complete
Location
GSK Investigational Site
Saint Louis, Missouri, United States, 63139
Status
Study Complete
Location
GSK Investigational Site
Brooklyn, New York, United States, 11230
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32806
Status
Study Complete
Location
GSK Investigational Site
South Miami, Florida, United States, 33143
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45242
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92103
Status
Study Complete
Location
GSK Investigational Site
Oklahoma, Oklahoma, United States, 73119
Status
Study Complete
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70115
Status
Study Complete
Location
GSK Investigational Site
Brandon, Florida, United States, 33511
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
Status
Study Complete
Location
GSK Investigational Site
Hialeah, Florida, United States, 33012
Status
Study Complete
Location
GSK Investigational Site
Port Orange, Florida, United States, 32127
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Duncansville, Pennsylvania, United States, 16635
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45255
Status
Study Complete
Location
GSK Investigational Site
Prairie Village, Kansas, United States, 66206
Status
Study Complete
Location
GSK Investigational Site
Crestview Hills, Kentucky, United States, 41017
Status
Study Complete
Location
GSK Investigational Site
Bellevue, Nebraska, United States, 68005
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14223
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45227
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60640
Status
Study Complete
Location
GSK Investigational Site
Oldsmar, Florida, United States, 34677
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78209
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85224
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
Status
Study Complete
Location
GSK Investigational Site
Savannah, Georgia, United States, 31406
Status
Study Complete
Location
GSK Investigational Site
Carmichael, California, United States, 95608
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2016-16-02
Actual study completion date
2016-16-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website