Phase 3
N=708
A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients With Osteoarthritis
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02311881 ↗Enrolled (actual)
708
Serious AEs
1.3%
Results posted
Apr 2017
Primary outcome: Primary: Time-weighted Mean Change From Baseline in Western Ontario McMaster (WOMAC) Pain Through Week 12 of Treatment — -28.25; -25.89; -25.74 millimeter(mm) — p=0.1626
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Paracetamol 1000 mg SR tablets (Drug); Paracetamol 665 mg SR tablets (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-weighted Mean Change From Baseline in Western Ontario McMaster (WOMAC) Pain Through Week 12 of Treatment |
-28.25; -25.89; -25.74 | 0.1626 |
| SECONDARY Time Weighted Mean Change From Baseline in WOMAC Physical Function Through Week 12 of Treatment |
-28.24; -26.23; -26.68 | — |
| SECONDARY Time Weighted Mean Change From Baseline in WOMAC Stiffness Through Week 12 of Treatment |
-27.68; -25.61; -26.16 | — |
| SECONDARY Time-weighted Mean Change From Baseline in WOMAC Total Index Through Week 12 of Treatment |
-0.28; -0.26; -0.27 | — |
| SECONDARY Mean Change From Baseline in Global Patient Assessment of Arthritis (GPAOA) |
68.23; 69.20; 69.79; 39.34; 41.46; 42.93 | — |
| SECONDARY Number of Participants Classified as Responder |
157; 148; 159 | — |
| SECONDARY Mean Change From Baseline in Daily Pain, Daily Stiffness and Pain/Stiffness (Composite) at Week 12 |
6.39; 6.27; 6.63; 3.80; 3.80; 3.82 | — |
| SECONDARY Mean Number of Rescue Medication Pills Taken Per Day up to 12 Weeks |
0.356; 0.200; 0.337 | — |
| SECONDARY Mean Change From Baseline in Chronic Pain Sleep Inventory (CPSI) |
60.40; 57.77; 61.30; 59.21; 57.19; 60.50 | — |
| SECONDARY Patient Global Assessment of Response to Therapy (PGART) |
2.50; 2.43; 2.25; 2.58; 2.40; 2.44 | — |
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 1.5xULN is acceptable)
- Other arthritis type, fibromyalgia or collagen vascular disease or secondary OA of study joint or chronic pain condition
Data sourced from ClinicalTrials.gov (NCT02311881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.