Trial Outcomes & Findings for A Within-subject Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness (NCT NCT02271854)

Results Overview

The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the modified ITT population. SPID 24 derived from Pain on Walking (POW) scores assessed over 24 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ \[T(i) - T(i-1)\] x \[((PID)(i-1) + PID(i))/2\] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

102 participants

Primary outcome timeframe

24 hours

Results posted on

2016-04-05

Participant Flow

Study Start 7 Oct 2014 and End 24 dec 2014

Participant milestones

Participant milestones
Measure	Diclofenac Sodium Gel 1% and Placebo Gel This study is a within-subject design i.e. diclofenac sodium gel 1% four times a day applied to one leg and placebo gel four times a day applied to the other leg to the other leg at the same time
Overall Study STARTED	102
Overall Study COMPLETED	98
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Diclofenac Sodium Gel 1% and Placebo Gel This study is a within-subject design i.e. diclofenac sodium gel 1% four times a day applied to one leg and placebo gel four times a day applied to the other leg to the other leg at the same time
Overall Study Withdrawal by Subject	2
Overall Study Unable or unwilling to cooperate with st	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

A Within-subject Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diclofenac Sodium Gel 1% n=86 Participants diclofenac sodium gel 1% applied four times daily Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily
Age, Continuous	27.5 years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Region of Enrollment United States	86 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the modified ITT population. SPID 24 derived from Pain on Walking (POW) scores assessed over 24 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ \[T(i) - T(i-1)\] x \[((PID)(i-1) + PID(i))/2\] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i.

Outcome measures

Outcome measures
Measure	Diclofenac Sodium Gel 1% n=86 Participants diclofenac sodium gel 1% applied four times daily Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily	Placebo n=86 Participants Placebo gel applied four times daily Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily
Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW.	50.15 units on a scale (NRS) Standard Deviation 35.95	54.83 units on a scale (NRS) Standard Deviation 37.04

SECONDARY outcome

Timeframe: 48 hours

Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) (POW) was a secondary outcome. Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) for the modified ITT population. SPID 48 derived from Pain on Walking (POW) scores assessed over 48 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 48 was computed using the trapezoidal rule, i.e. Σ \[T(i) - T(i-1)\] x \[((PID)(i-1) + PID(i))/2\] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i.

Outcome measures

Outcome measures
Measure	Diclofenac Sodium Gel 1% n=86 Participants diclofenac sodium gel 1% applied four times daily Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily	Placebo n=86 Participants Placebo gel applied four times daily Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily
Sum of Pain Intensity Differences Over 48 Hours After Initiating Treatment (SPID 48), Derived From POW.	151.8 units on a scale (NRS) Standard Deviation 81.9	160.84 units on a scale (NRS) Standard Deviation 83.15

Adverse Events

Diclofenac Sodium Gel 1%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director Clinical Research pain category

Novartis Consumer Health a GSK Consumer Healthcare company

Phone: +413635528

Results disclosure agreements

Principal investigator is a sponsor employee Preliminary agreement between Novartis Consumer Health and the investigator
Publication restrictions are in place

Restriction type: OTHER