NCT02104050

A Phase 2b Randomized, Double-Blind, Vehicle-Controlled, Repeat-Dose, Multi- Center, 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 2 October 2017

What this trial tests

Phase 2 trial testing Placebo Gel in Osteoarthritis in 202 participants. Completed in 1 August 2015.

Timeline

1 April 2014

Primary endpoint
1 August 2015

1 August 2015

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	202
Start date	1 April 2014
Primary completion	1 August 2015
Estimated completion	1 August 2015
Sites	13 locations across United States

Drugs / interventions tested

• Placebo Gel
• OLT1177 Gel — full drug profile →

Conditions studied

• Osteoarthritis — all drugs for Osteoarthritis →
• Pain — all drugs for Pain →

Sponsor

Olatec Therapeutics LLC — full company profile →

Who can join

Adults 45 to 80, any sex, with Osteoarthritis or Pain. 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.

• Pain on Movement
  Time frame: Baseline to Week 6
  Subjects will record their level of Pain on Movement in the target knee on a 100-mm VAS scale (with anchors 0=no pain; 100=extreme pain) in response to the question, 'How do you estimate the average amount of your study knee pain while moving during your daily activities within the last 24 hours?'

Sponsor's own description

The objectives of this trial are to investigate the efficacy and safety of six weeks of treatment with 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. Osteoarthritis Pain.
   Yu H, Huang T, Lu WW, Tong L, et al · · 2022 · cited 93× · PMID 35563035 · DOI 10.3390/ijms23094642
3. Human Autoinflammatory Diseases Mediated by NLRP3-, Pyrin-, NLRP1-, and NLRC4-Inflammasome Dysregulation Updates on Diagnosis, Treatment, and the Respective Roles of IL-1 and IL-18.
   Alehashemi S, Goldbach-Mansky R. · · 2020 · cited 78× · PMID 32983099 · DOI 10.3389/fimmu.2020.01840
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. 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
6. Inflammasomes and the IL-1 Family in Bone Homeostasis and Disease.
   Tseng HW, Samuel SG, Schroder K, Lévesque JP, et al · · 2022 · cited 21× · PMID 35567665 · DOI 10.1007/s11914-022-00729-8
7. The involvement of signaling pathways in the pathogenesis of osteoarthritis: An update.
   Fazio A, Di Martino A, Brunello M, Traina F, et al · · 2024 · cited 20× · PMID 39021400 · DOI 10.1016/j.jot.2024.06.002
8. Possible therapeutic targets for NLRP3 inflammasome-induced breast cancer.
   Wang X, Lin J, Wang Z, Li Z, et al · · 2023 · cited 12× · PMID 37300757 · DOI 10.1007/s12672-023-00701-7