Muscle SorenessPhase 3NCT02271854

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

A Phase 3 study testing Diclofenac sodium gel 1% in people with Muscle Soreness, run by Novartis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with DOMS Read more about this study

Who is it for?: Ages 18 to 35 years
Conditions the study is for: Muscle Soreness
What is being tested?: Diclofenac sodium gel 1%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 102 participants
Where: 1 siteUnited States
Study dates: Oct 2014to Dec 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male or female subjects aged 18-35 years
Not engaged in regular lower extremity fitness activities in the past 6 months prior to screening
Willing to refrain from use of ice, heat and massage during the study
DOMS score ≥4 Pain at Rest (PAR) and a DOMS score ≥5 Pain on Walking (POW), with moderate or severe on categorical scale

Who cannot join

Pain medication \& corticosteroids prior to randomization
Topical analgesic or anti-inflammatory treatment over the previous month
Body mass index of >32 kg/m2
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

United States1 site

Lotus Clinical Research, 100 W California Blvd,
Pasadena, California, 91105

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Within-subject Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied Four Times Daily in Subjects Experiencing Acute Delayed Onset Muscle Soreness (DOMS) of the Lower Limbs

This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with DOMS

Conditions: Muscle Soreness
Being tested: Diclofenac sodium gel 1%, Placebo
Medical subject headings: Myalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diclofenac sodium gel 1%Drug
Diclofenac sodium gel 1% four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over).
PlaceboDrug
Placebo gel four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over).

Study groups in NCT02271854
Study group	Role	What they receive
diclofenac sodium gel 1%	Experimental	diclofenac sodium gel 1% applied four times daily Receives: Drug: Diclofenac sodium gel 1%; Drug: Placebo
Placebo	Placebo comparator	Placebo gel applied four times daily Receives: Drug: Diclofenac sodium gel 1%; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW.
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.
Measured: 24 hours

Secondary outcomes (1)

Sum of Pain Intensity Differences Over 48 Hours After Initiating Treatment (SPID 48), Derived From POW.
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.
Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Dec 2014

First posted22 Oct 2014 (estimated)
Study startOct 2014
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Muscle SorenessStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02271854
Sponsor's protocol ID: 197-P-323
Status last verified: Mar 2016
First submitted: 20 Oct 2014
Last updated: 5 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Recruiting
Mineral-Infused Clothing for Recovery From Muscle Soreness and Muscle Damage After Exercise
Delayed Onset Muscle Soreness, Exercise-Induced Muscle Damage
Not yet recruiting
Clinical and MRI Characteristics of Delayed Onset Muscle Soreness (DOMS) of the Shoulder Rotator Muscles Induced by Eccentric Exercise: An Exploratory Prospective Experimental Study
Delayed Onset Muscle Soreness Experimentally Induced
Not yet recruitingObservational study
A Study to Evaluate the Analgesic Properties of Topically Applied Menthol in Marathon Participants
Muscle Soreness

All Muscle Soreness trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Within-subject Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied Four Times Daily in Subjects Experiencing Acute Delayed Onset Muscle Soreness (DOMS) of the Lower Limbs
ClinicalTrials.gov ID: NCT02271854
Acronym / sponsor ID: 197-P-323
Conditions: Muscle Soreness
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 22 Oct 2014 (estimated)
Results: Posted 5 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with DOMS

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
diclofenac sodium gel 1%	Experimental	Drug: Diclofenac sodium gel 1%, Drug: Placebodiclofenac sodium gel 1% applied four times daily
Placebo	Placebo comparator	Drug: Diclofenac sodium gel 1%, Drug: PlaceboPlacebo gel applied four times daily

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Male or female subjects aged 18-35 years
Not engaged in regular lower extremity fitness activities in the past 6 months prior to screening
Willing to refrain from use of ice, heat and massage during the study
DOMS score ≥4 Pain at Rest (PAR) and a DOMS score ≥5 Pain on Walking (POW), with moderate or severe on categorical scale

Key exclusion criteria (4 listed)

Pain medication \& corticosteroids prior to randomization
Topical analgesic or anti-inflammatory treatment over the previous month
Body mass index of >32 kg/m2
Other protocol-defined inclusion/exclusion criteria may apply

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diclofenac sodium gel 1%Diclofenac sodium gel 1% four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over).	Drug	Placebo, diclofenac sodium gel 1%
PlaceboPlacebo gel four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over).	Drug	Placebo, diclofenac sodium gel 1%

Primary outcome

Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW.
Time frame: 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.

1 secondary outcome

Sum of Pain Intensity Differences Over 48 Hours After Initiating Treatment (SPID 48), Derived From POW.
Time frame: 48 hours

Results and safety

Results posted to the registry on 5 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diclofenac Sodium Gel 1% and Placebo Gel	102	98

Primary outcome: Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW.

Time frame: 24 hours. Mean (Standard Deviation). Unit: units on a scale (NRS)

Measure	Diclofenac Sodium Gel 1% n = 86	Placebo n = 86
Value	50.15 (35.95)	54.83 (37.04)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diclofenac Sodium Gel 1%	0 of 102 (0%)	0 of 102 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Muscle Soreness

Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Recruiting
Mineral-Infused Clothing for Recovery From Muscle Soreness and Muscle Damage After Exercise
Delayed Onset Muscle Soreness, Exercise-Induced Muscle Damage
Not yet recruiting
Clinical and MRI Characteristics of Delayed Onset Muscle Soreness (DOMS) of the Shoulder Rotator Muscles Induced by Eccentric Exercise: An Exploratory Prospective Experimental Study
Delayed Onset Muscle Soreness Experimentally Induced
Not yet recruitingObservational study
A Study to Evaluate the Analgesic Properties of Topically Applied Menthol in Marathon Participants
Muscle Soreness

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Diclofenac sodium gel 1% in people with Muscle Soreness, run by Novartis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW. (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02271854.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2016.