A Phase 3 interventional study of Esflurbiprofen and Diclofenac diethylamine in Osteoarthritis Knee Pain, sponsored by Taisho Pharmaceutical Co., Ltd.. Completed at 11 sites in Indonesia. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2021-08-20.
Sponsored by Taisho Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
Among 17 studies in Osteoarthritis, Knee with a site in Indonesia — 3 open to participants now, 4 under way, 1 of them phase 3. Osteoarthritis, Knee · Indonesia.
Among the 17 studies in Osteoarthritis, Knee with a site in Indonesia, this one has the largest enrollment of the 16 interventional ones that give a count, is the only one that started in 2018, is one of 2 in phase 3, and was the 1st registered.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
Browse Osteoarthritis, Knee studies →3 of the 17 studies in Osteoarthritis, Knee with a site in Indonesia are open now. Recruiting first, the newest first:
Gadjah Mada University · Sites in Indonesia
Universitas Indonesia · Sites in Indonesia
Universitas Sriwijaya · Sites in Indonesia
A study can be open while its sites in Indonesia have not opened yet or have stopped. Only those recruiting at a site in Indonesia →
Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.
This study: 40 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 5 · Phase 3 3 · Phase 4 1
First in 2015; this study’s year is marked. 1 started in 2018.
This study's enrollment of 313 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Median enrollment 44 across the 16 interventional studies, 120 across the 1 observational. Of the 12 that completed or were terminated, 1 (8%) have results posted.
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2 of 17 have an industry lead sponsor. The 10 most frequent:
Taisho Pharmaceutical Co., Ltd. is the lead sponsor of 43 studies on the registry; 3 are open to participants now.
Taisho Pharmaceutical Co., Ltd. has 1 study filed under Osteoarthritis, Knee — fewer than ten, so there is no comparison to draw.
1 of the studies in Osteoarthritis, Knee with a site in Indonesia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07833462Universitas IndonesiaEfficacy of Thread-Embedding Acupuncture Using the Longitudinal Oblique Technique From BL40 Toward BL57 on KOOS Scores and Joint Range of Motion in Knee Osteoarthritis | 2026-11-18 |
Among the 17 studies in Osteoarthritis, Knee with a site in Indonesia, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The objectives of this study are to demonstrate the non-inferiority of esflurbiprofen plaster (SFPP) 40 mg applied for 2 weeks to diclofenac gel, the comparator, in terms of efficacy in patients with knee osteoarthritis (OA) and to examine the safety of SFPP.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A plaster containing 40 mg of Esflurbiprofen and 36.2 mg of Japanese Pharmacopoeia mentha oil per patch (10 × 14 cm)
Drug: Esflurbiprofen
A gel containing 11.6 mg of Diclofenac diethylamine (equivalent to 10 mg of diclofenac sodium) per 1 g (1 tube contains 20 g)
Drug: Diclofenac diethylamine
A plaster containing 40 mg of Esflurbiprofen and 36.2 mg of Japanese Pharmacopoeia mentha oil per patch (10 × 14 cm)
A gel containing 11.6 mg of Diclofenac diethylamine (equivalent to 10 mg of diclofenac sodium) per 1 g (1 tube contains 20 g)
Improvement of Knee pain on rising from the chair
0-100 mm Visual Analogue Scale (VAS) (0mm, no pain; 100mm, worst pain ever)
Time frame: 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)
Improvement of Changes in total clinical symptom
Assessment from investigator ( 0=Absent, 1=Mild, 2=Moderate, 3=Severe; total= 0 - 45 )
Time frame: 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)
Improvement of Investigator's global assessment
Investigator's global assessment Questionnaire ( 1=Marked, 2=Moderate, 3=Mild, 4=No change, 5=Worse)
Time frame: Last visit
Improvement of Patient's global assessment
Patient's global assessment Questionnaire ( 1=Marked, 2=Moderate, 3=Mild, 4=No change, 5=Worse )
Time frame: Last visit
Improvement of Knee pain on walking
0-100 mm Visual Analogue Scale (VAS) (0mm, no pain; 100mm, worst pain ever)
Time frame: 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)
Number of Rescue drug use during treatment period
Report from investigator
Time frame: 3 weeks (1 weeks of observation period and follow up with 2 weeks treatment period)
Number of Adverse events and adverse drug reactions
Report from investigator
Time frame: 5 weeks (3 weeks of observation period and follow up with 2 weeks treatment period)
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Jan 2021, 35 months.
Of 65 industry-sponsored phase 3 interventional studies under Osteoarthritis, Knee, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 27. This study's 35 months is above that.
Counting every sponsor, half of 100 studies reached it within 21 months; a quarter within 15 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Taisho Pharmaceutical Co., Ltd. →