Last reviewed · How we verify
NCT03556787
An Evaluation of a Gender Specific Insole to Provide Relief From Knee Pain Due to Osteoarthritis or General Anterior Knee Pain in Male Subjects When Used in Foot Wear Over a Period of Four Weeks
NA trial testing BPI 1000013 (Dr Scholls Insole) in Osteoarthritis, Knee in 89 participants. Completed in 8 November 2018.
8 November 2018
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 89 |
| Start date | 4 June 2018 |
| Primary completion | 8 November 2018 |
| Estimated completion | 8 November 2018 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- BPI 1000013 (Dr Scholls Insole)
Conditions studied
- Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →
Sponsor
Bayer — full company profile →
Who can join
Adults 18 to 70, male only, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of this trial is to demonstrate the ability of a full length foam insole to provide relief from pain due to osteoarthritis of the knee or general knee pain when used in foot wear for a 4-week period of time. The secondary objectives comprise the evaluation of the insole's ability to provide appropriate shoe fit and comfort as well as relief from osteoarthritis/ general knee pain after short-term use. The safety and tolerability of the test articles in terms of adverse events (AE) will also be investigated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03556787
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Osteoarthritis, Knee
Currently open trials in the same condition.
- NCT07509307 — AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee · Phase 3 · recruiting
- NCT06488144 — Rehabilitation for Arthritis of The Knee: mainTaining Improvement for Veterans · Phase 3 · recruiting
- NCT07386561 — Virtual Reality Therapy and Non-Sleep Deep Rest Relaxation After Joint Arthroplasty · NA · active not recruiting
- NCT07514598 — Effect of J-Shaped Incision After Total Knee Arthroplasty (J-TKA) · NA · active not recruiting
- NCT07058623 — Nurse-Led Telehealth vs In-Person Follow-Up After Total Knee Replacement · NA · recruiting
Other Bayer trials
Trials by the same sponsor.
- NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
- NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
- NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03556787 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 23 November 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03556787.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing