Trial Outcomes & Findings for The Efficacy of Diclofenac Gel for Breakthrough Pain and the Neuropathic Components of Pain in Knee Osteoarthritis (NCT NCT01383954)

Results Overview

Participants assessed their knee pain using a visual analog scale (VAS) where 0=no pain and 100=worst possible pain. Pain scores were recorded in an electronic diary prior to and 4 hours after the first daily application of diclofenac gel for breakthrough pain. The daily percent change in pain scores over the 7 days prior to Week 1 were averaged. Percent change from Baseline (average pain score 7 days prior to first treatment) was calculated as (value at baseline - value at post-baseline visit) / (value at baseline) x 100. A positive change from Baseline indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

52 participants

Primary outcome timeframe

Baseline and Week 1

Results posted on

2017-08-15

Participant Flow

Participant milestones

Participant milestones
Measure	Diclofenac Gel Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
Overall Study STARTED	52
Overall Study Safety Population: Received Treatment	48
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Diclofenac Gel Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
Overall Study Lack of Efficacy	2
Overall Study Electronic Diary Too Cumbersome to Use	2
Overall Study Adverse Event	1
Overall Study Reason Not Specified	9

Baseline Characteristics

The Efficacy of Diclofenac Gel for Breakthrough Pain and the Neuropathic Components of Pain in Knee Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diclofenac Gel n=38 Participants Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
Age, Continuous	56.8 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 1

Population: Modified Intent-to-Treat Population, all participants who completed at least 50% of the study (at least 2 weeks of drug treatment), who had pain data available for analysis at the given timepoints.

Participants assessed their knee pain using a visual analog scale (VAS) where 0=no pain and 100=worst possible pain. Pain scores were recorded in an electronic diary prior to and 4 hours after the first daily application of diclofenac gel for breakthrough pain. The daily percent change in pain scores over the 7 days prior to Week 1 were averaged. Percent change from Baseline (average pain score 7 days prior to first treatment) was calculated as (value at baseline - value at post-baseline visit) / (value at baseline) x 100. A positive change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Diclofenac Gel n=38 Participants Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
Percent Change From Baseline in Pain Score During Week 1	33.3 percent change Standard Deviation 23.7

PRIMARY outcome

Timeframe: Baseline and Week 2

Population: Modified Intent-to-Treat Population, all participants who completed at least 50% of the study (at least 2 weeks of drug treatment), who had pain data available for analysis at the given timepoints.

Participants assessed their knee pain using a visual analog scale (VAS) where 0=no pain and 100=worst possible pain. Pain scores were recorded in an electronic diary prior to and 4 hours after the first daily application of diclofenac gel for breakthrough pain. The daily percent change in pain scores over the 7 days prior to Week 2 were averaged. Percent change from baseline (average pain score 7 days prior to first treatment) was calculated as (value at baseline - value at post-baseline visit)/ (value at baseline) x 100. A positive change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Diclofenac Gel n=37 Participants Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
Percent Change From Baseline in Pain Score During Week 2	33.3 percent change Standard Deviation 23.7

Adverse Events

Diclofenac Gel

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Diclofenac Gel n=48 participants at risk Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
Skin and subcutaneous tissue disorders Rash	2.1% 1/48

Additional Information

Ajay D. Wasan, M.D., M.Sc.

Brigham and Women's Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place