Ignite Creation Date:
2024-05-06 @ 2:09 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04224584
Status:
COMPLETED
Last Update Posted:
2022-02-16
First Post:
2020-01-06
Brief Title:
A Mechanism Based Proof of Concept Study of the Effects of Duloxetine in the Treatment of Patients With Osteoarthritic Knee Pain
Sponsor:
Kristian Kjær Petersen
Organization:
Aalborg University
Study Overview
Official Title:
A Mechanism Based Proof of Concept Study of the Effects of Duloxetine in the Treatment of Patients With Osteoarthritic Knee Pain
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Duloxetine provides an analgesic effect of patients with OA The mode of action of duloxetine is partly believed to act through modulating the descending inhibitory pain pathways from the brainstem towards the spinal cord thereby dampening pain by gating the afferent pain signals from the periphery during their passage to the brain This study aims to investigate if the analgesic effect of duloxetine is due to modulation of pain mechanisms
Study Rationale The present study will utilize a set of quantitative pain biomarkers developed to assess peripheral and central manifestations in OA and the influence of duloxetine on those manifestations
Treatment Patients will be randomized to one of two treatment sequences
1 Sequence 1 20 mg duloxetine QD for 1 week 40 mg Duloxetine QD for 1 week 60 mg duloxetine QD for 10 weeks 40 mg duloxetine QD for 1 week 20 mg duloxetine QD for 1 week followed by 14 weeks of corresponding placebo
2 Sequence 2 14 weeks of placebo followed by 20 mg Duloxetine QD for 1 week 40 mg duloxetine QD for 1 week 60 mg duloxetine QD for 10 weeks 40 mg duloxetine QD for 1 week and 20 mg duloxetine QD for 1 week
The two treatment periods of 14 weeks each are separated by a washout period of two weeks and include a two-week titration period
Primary Objective To assess the effect of 60 mg daily maintenance dose administration of Duloxetine for 10 weeks compared with placebo on pain mechanisms
Sample Size JustificationStatistics The sample size was calculated to 32 patients providing a power of 85 with a significant level of 005 to detect a group difference of 1 point in the change from baseline of the week 12 mean of 24-hour worst pain between duloxetine and placebo treatment
Patient Selection Up to 40 patients with osteoarthritic knee pain will be enrolled in this study in order to complete 32 patients
Study sites
Mech-Sense Aalborg University Hospital DK-9000 Aalborg Denmark Study Assessments As the primary objective of this study is the assessment of which pain mechanisms are modulated by administration of the study drug the primary endpoints will be Experimental Mechanism Based Pain Measures EPMs including 1 Pressure Pain Thresholds PPTs Temporal Summation Conditioned Pain Modulation CPM and Offset Analgesia In addition efficacy will be evaluated using 1 pain severity worst daily pain and night pain 2 Pittsburgh Sleep Quality Index PSQI 3 Brief Pain Inventory BPI 4 Investigator and Patient Global Assessment of Changes IGIC and PGAC 5 Western Ontario and MacMaster WOMAC OA physical function 6 PainDetect and 7 Central Sensitization Index CSI
Safety Discontinuation rates and Treatment Emergent Adverse Events TEAEs Key InclusionExclusion Criteria Males or females between 40 and 75 years of age who are postmenopausal or using allowed contraception methods and have a Body Mass Index BMI between 20-35 kgm2 inclusive Patient with unilateral or bilateral OA of knee diagnosed according to the American College of Rheumatology ACR criteria based on clinical and radiographic evidence with pain severity equal to or higher than 5 on a Visual Analogue Scale VAS assessed as the worst pain within the last 24 hours
Study Rationale The present study will utilize a set of quantitative pain biomarkers developed to assess peripheral and central manifestations in OA and the influence of duloxetine on those manifestations
Treatment Patients will be randomized to one of two treatment sequences
1 Sequence 1 20 mg duloxetine QD for 1 week 40 mg Duloxetine QD for 1 week 60 mg duloxetine QD for 10 weeks 40 mg duloxetine QD for 1 week 20 mg duloxetine QD for 1 week followed by 14 weeks of corresponding placebo
2 Sequence 2 14 weeks of placebo followed by 20 mg Duloxetine QD for 1 week 40 mg duloxetine QD for 1 week 60 mg duloxetine QD for 10 weeks 40 mg duloxetine QD for 1 week and 20 mg duloxetine QD for 1 week
The two treatment periods of 14 weeks each are separated by a washout period of two weeks and include a two-week titration period
Primary Objective To assess the effect of 60 mg daily maintenance dose administration of Duloxetine for 10 weeks compared with placebo on pain mechanisms
Sample Size JustificationStatistics The sample size was calculated to 32 patients providing a power of 85 with a significant level of 005 to detect a group difference of 1 point in the change from baseline of the week 12 mean of 24-hour worst pain between duloxetine and placebo treatment
Patient Selection Up to 40 patients with osteoarthritic knee pain will be enrolled in this study in order to complete 32 patients
Study sites
Mech-Sense Aalborg University Hospital DK-9000 Aalborg Denmark Study Assessments As the primary objective of this study is the assessment of which pain mechanisms are modulated by administration of the study drug the primary endpoints will be Experimental Mechanism Based Pain Measures EPMs including 1 Pressure Pain Thresholds PPTs Temporal Summation Conditioned Pain Modulation CPM and Offset Analgesia In addition efficacy will be evaluated using 1 pain severity worst daily pain and night pain 2 Pittsburgh Sleep Quality Index PSQI 3 Brief Pain Inventory BPI 4 Investigator and Patient Global Assessment of Changes IGIC and PGAC 5 Western Ontario and MacMaster WOMAC OA physical function 6 PainDetect and 7 Central Sensitization Index CSI
Safety Discontinuation rates and Treatment Emergent Adverse Events TEAEs Key InclusionExclusion Criteria Males or females between 40 and 75 years of age who are postmenopausal or using allowed contraception methods and have a Body Mass Index BMI between 20-35 kgm2 inclusive Patient with unilateral or bilateral OA of knee diagnosed according to the American College of Rheumatology ACR criteria based on clinical and radiographic evidence with pain severity equal to or higher than 5 on a Visual Analogue Scale VAS assessed as the worst pain within the last 24 hours
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None