NCT01768975

Randomized, Double-Blind, Vehicle-Controlled, Efficacy and Safety Clinical Trial of Topically Applied OLT1177 Gel in Subjects With Moderate to Severe Pain Associated With Osteoarthritis of the Knee Following Cessation of Pain Therapy

Completed Phase 2 Last updated 25 September 2014

What this trial tests

Phase 2 trial testing OLT1177 Gel in Osteoarthritis of the Knee in 79 participants. Completed in 1 August 2013.

Timeline

1 January 2013

Primary endpoint
1 August 2013

1 August 2013

Quick facts

Lead sponsor	Olatec Therapeutics LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	79
Start date	1 January 2013
Primary completion	1 August 2013
Estimated completion	1 August 2013
Sites	3 locations across United States

Drugs / interventions tested

• OLT1177 Gel — full drug profile →
• Placebo gel

Conditions studied

• Osteoarthritis of the Knee — all drugs for Osteoarthritis of the Knee →

Sponsor

Olatec Therapeutics LLC — full company profile →

Who can join

Adults 35 to 80, any sex, with Osteoarthritis of the Knee. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in WOMAC knee pain subscale (scale 0 - 20)
  Time frame: 14 days
  The mean group change for OLT1177 Gel and vehicle control from Baseline (Day 0) to Day 14 in WOMAC knee pain subscale (Scale 0-20), which is determined by the subjects responses to five questions (S1-S5) using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4)

Sponsor's own description

The purpose of this trial is to investigate the efficacy and safety of OLT1177 Gel in subjects with moderate to severe pain associated with osteoarthritis of the knee following cessation of pain therapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The role of inflammasomes in human diseases and their potential as therapeutic targets.
   Yao J, Sterling K, Wang Z, Zhang Y, et al · · 2024 · cited 135× · PMID 38177104 · DOI 10.1038/s41392-023-01687-y
2. Role of inflammasomes in the pathogenesis of periodontal disease and therapeutics.
   Marchesan JT, Girnary MS, Moss K, Monaghan ET, et al · · 2020 · cited 96× · PMID 31850638 · DOI 10.1111/prd.12269
3. DC ENaC-Dependent Inflammasome Activation Contributes to Salt-Sensitive Hypertension.
   Pitzer A, Elijovich F, Laffer CL, Ertuglu LA, et al · · 2022 · cited 88× · PMID 35862128 · DOI 10.1161/circresaha.122.320818
4. NLRP3 inflammasome: a key player in the pathogenesis of life-style disorders.
   Ramachandran R, Manan A, Kim J, Choi S. · · 2024 · cited 67× · PMID 38945951 · DOI 10.1038/s12276-024-01261-8
5. Targeting the NLRP3 inflammasome for inflammatory disease therapy.
   Cabral JE, Wu A, Zhou H, Pham MA, et al · · 2025 · cited 57× · PMID 40374417 · DOI 10.1016/j.tips.2025.04.007
6. Role of NLRP3 Inflammasome in Parkinson's Disease and Therapeutic Considerations.
   Nguyen LTN, Nguyen HD, Kim YJ, Nguyen TT, et al · · 2022 · cited 57× · PMID 35988226 · DOI 10.3233/jpd-223290
7. Perspectives in primary hyperoxaluria - historical, current and future clinical interventions.
   Shee K, Stoller ML. · · 2022 · cited 41× · PMID 34880452 · DOI 10.1038/s41585-021-00543-4
8. Screening NLRP3 drug candidates in clinical development: lessons from existing and emerging technologies.
   Tengesdal IW, Banks M, Dinarello CA, Marchetti C. · · 2024 · cited 21× · PMID 39188718 · DOI 10.3389/fimmu.2024.1422249