PainPhase 4NCT02087748
An Investigator Initiated, Within-Subject, Proof of Concept Study to Assess the Efficacy and Safety of Voltaren Gel in Subjects With DOMS
A Phase 4 study testing 1% diclofenac sodium gel in people with Pain and Delayed Onset Muscle Soreness, run by Lotus Clinical Research, LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate analgesic efficacy of Topical Voltaren Gel (diclofenac sodium gel) 1% applied QID compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Delayed Onset Muscle Soreness
- What is being tested?
- 1% diclofenac sodium gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to May 2014
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who provide written informed consent prior to enrollment
- Male or female and 18 to 35 years of age.
- Patients who are not engaged in regular lower extremity fitness activities for more than 2 times per week for ≥2 consecutive weeks in the past 6 months prior to screening.
- Female patients are eligible only if all of the following apply:
- Not pregnant (subjects of child bearing potential must have a negative beta human chorionic gonadotropin (β-hCG) pregnancy test at screening);
- Not lactating;
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- Not planning to become pregnant within the duration of the study;
- Patients who are willing and capable of understanding and cooperating with the requirements of the study.
- Patients able to understand and communicate in English.
- Randomization Inclusion Criteria:
- Patients who report a DOMS score ≥4 at rest (numerical rating scale of 0 to 10, where 0 is no pain and 10 is worst pain imaginable) secondary to delayed muscle soreness on both right and left legs. The DOMS scores at rest reported for each leg must be within 3 points of each other.
- Patients must report a categorical pain rating of moderate to severe for each leg on a scale of none, mild, moderate, or severe prior to randomization.
Who cannot join
- Have a body mass index of >32 kg/m2
- History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening.
- Psychiatric disease including major depression, bipolar disorder, or anxiety, or other medical condition that, in the opinion of the Investigator, would interfere with the evaluation of study drug efficacy or safety
- History of clinically significant cardiovascular, cerebrovascular, metabolic, pulmonary, neurological, hematological, autoimmune, psychiatric or endocrine disorders, including individuals with Type I or Type II diabetes, or other clinically significant medical condition that, in the opinion of the Investigator, may preclude safe study participation.
- Have had surgery or scheduled to undergo surgery of the hips or knees within 6 months prior to screening and/or during the study participation.
- Have significant biomechanical abnormality in the lower extremity that would preclude study evaluations, such as: peripheral or central neurological disease, significant back pain; symptomatic osteoarthritis of the hips, knew, or feet, or other painful conditions of the lower extremities.
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- Have any type of orthopedic and/or prosthetic device or any skin abnormalities on the legs that may interfere with local tolerability.
- Currently taking corticosteroids or topical analgesic or anti inflammatory treatment whose the duration of action may affect study evaluations.
- Malignancy in the last 5 years, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin that has been surgically cured, or any Stage 1 cancer or carcinoma in situ cured by resection or localized radiation at least 5 years prior to screening with no evidence of recurrence.
- History of allergy (cutaneous or systemic), hypersensitivity, or asthma to any of the following: diclofenac, paracetamol, acetylsalicylic acid, salicylic acid, other NSAID or cyclooxygenase 2-specific inhibitor (COXIB) or known intolerance (cutaneous or systemic) to any of the ingredients in the gel, such as isopropyl alcohol or propylene glycol.
- History of known narcotic, analgesic, or alcohol abuse.
- Any cognitive impairment that would, in the opinion of the Investigator, preclude study participation or compliance with study procedures (e.g., Alzheimer's dementia).
- Previously received an investigational product within 30 days before the scheduled dose of study medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lotus Clinical Research, LLC
Pasadena, California, 91105
About this study
Official title: A Randomized, Double-Blind, Within-Subject, Proof of Concept Study to Assess the Analgesic Efficacy and Safety of Voltaren Gel (1% Diclofenac Sodium) Compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness
The purpose of this study is to evaluate analgesic efficacy of Topical Voltaren Gel (diclofenac sodium gel) 1% applied QID compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness.
Read the detailed description
The purpose of this randomized, double-blind, placebo controlled, within-subject study is to evaluate the efficacy of topical diclofenac sodium gel (DSG) 1% in reducing pain associated with delayed onset muscle soreness (DOMS). Following exercise, subjects reporting significant DOMS received topical DSG 1% applied to 1 leg and placebo applied to the other every 6 hours for 48 hours.
- Conditions
- Pain, Delayed Onset Muscle Soreness
- Being tested
- 1% diclofenac sodium gel, Placebo
- Keywords
- DOMS
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% diclofenac sodium gelDrug
Also called Voltaren
Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours
PlaceboDrug
Also called Matching placebo
Placebo gel 4gm applied topically Q6 hour for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| 1% diclofenac sodium gel | Active comparator | Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours Receives: Drug: 1% diclofenac sodium gel |
| Placebo | Placebo comparator | Placebo gel 4gm applied topically Q6 hour for 48 hours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Reduction in SPID Scores of DOMS on Walking Over 24 Hours
The primary outcome is the analgesic efficacy of Topical Voltaren® gel compared to placebo in the reduction of the pain associated with DOMS. The statistical comparison of interest will be the mean reduction in DOMS scores upon walking in the leg receiving Topical Voltaren® gel vs the leg receiving placebo over the first 24 hours post treatment. Pain intensity was assessed at predefined time points (Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Rating Scale (NPRS) where a score of zero indicates "no pain" and "10" indicates "pain as bad as you can imagine". Pain Intensity Differences at each predefined time point (calculated as post-baseline NPRS values - baseline NPRS values) were analyzed. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -50 (indicative of an increase in pain) to 50 (indicative of a decrease in pain).
Measured: 7 days
Secondary outcomes (2)
Mean Reduction in SPID Scores of DOMS at Rest Over 24 Hours
The secondary outcome is the mean reduction in DOMS scores at rest in the leg receiving Topical Voltaren® gel versus the leg receiving placebo over the first 24 hours post treatment initiation.
Pain intensity was assessed at predefined time points (at Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Rating Scale (NPRS) where a score of zero indicates "no pain" and a score of 10 indicates "pain as bad as you can imagine". Pain Intensity Differences at each predefined time point (calculated as post-baseline NPRS values - baseline NPRS values) were analyzed. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -50 (indicative of an increase in pain) to 50 (indicative of a decrease in pain).
Measured: 7 days
Mean Reduction in SPID Scores of DOMS While Standing Over 24 Hours
The secondary outcome is the mean reduction in DOMS scores while standing in the leg receiving Topical Voltaren® gel versus the leg receiving placebo over the first 24 hours post treatment initiation.
Pain intensity was assessed at predefined time points (at Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Rating Scale (NPRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Pain Intensity Differences at each predefined time point (calculated as post-baseline NPRS values - baseline NPRS values) were analyzed. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -50 (indicative of an increase in pain) to 50 (indicative of a decrease in pain).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2014
- Study completionMay 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 PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lotus Clinical Research, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Neil Singla, Lotus Clinical Research, LLC
- Investigators
- Neil Singla, MD, Principal investigator, Lotus Clinical Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087748
- Sponsor's protocol ID
- LCR-VOL-01C
- Status last verified
- Dec 2014
- First submitted
- 12 Mar 2014
- Last updated
- 10 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Within-Subject, Proof of Concept Study to Assess the Analgesic Efficacy and Safety of Voltaren Gel (1% Diclofenac Sodium) Compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness
- ClinicalTrials.gov ID
- NCT02087748
- Acronym / sponsor ID
- LCR-VOL-01C
- Conditions
- Pain, Delayed Onset Muscle Soreness
- Keywords
- DOMS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lotus Clinical Research, LLCUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Posted 10 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate analgesic efficacy of Topical Voltaren Gel (diclofenac sodium gel) 1% applied QID compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness.
Detailed description
The purpose of this randomized, double-blind, placebo controlled, within-subject study is to evaluate the efficacy of topical diclofenac sodium gel (DSG) 1% in reducing pain associated with delayed onset muscle soreness (DOMS). Following exercise, subjects reporting significant DOMS received topical DSG 1% applied to 1 leg and placebo applied to the other every 6 hours for 48 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1% diclofenac sodium gel | Active comparator | Drug: 1% diclofenac sodium gelDiclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo gel 4gm applied topically Q6 hour for 48 hours |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Patients who provide written informed consent prior to enrollment
- Male or female and 18 to 35 years of age.
- Patients who are not engaged in regular lower extremity fitness activities for more than 2 times per week for ≥2 consecutive weeks in the past 6 months prior to screening.
- Female patients are eligible only if all of the following apply:
- Patients who are willing and capable of understanding and cooperating with the requirements of the study.
Key exclusion criteria (13 listed)
- Have a body mass index of >32 kg/m2
- History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening.
- Psychiatric disease including major depression, bipolar disorder, or anxiety, or other medical condition that, in the opinion of the Investigator, would interfere with the evaluation of study drug efficacy or safety
- History of clinically significant cardiovascular, cerebrovascular, metabolic, pulmonary, neurological, hematological, autoimmune, psychiatric or endocrine disorders, including individuals with Type I or Type II diabetes, or other clinically significant medical condition that, in the opinion of the Investigator, may preclude safe study participation.
- Have had surgery or scheduled to undergo surgery of the hips or knees within 6 months prior to screening and/or during the study participation.
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 |
|---|---|---|
| 1% diclofenac sodium gelAlso: VoltarenDiclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours | Drug | 1% diclofenac sodium gel |
| PlaceboAlso: Matching placeboPlacebo gel 4gm applied topically Q6 hour for 48 hours | Drug | Placebo |
Primary outcome
Mean Reduction in SPID Scores of DOMS on Walking Over 24 Hours
Time frame: 7 days
The primary outcome is the analgesic efficacy of Topical Voltaren® gel compared to placebo in the reduction of the pain associated with DOMS. The statistical comparison of interest will be the mean reduction in DOMS scores upon walking in the leg receiving Topical Voltaren® gel vs the leg receiving placebo over the first 24 hours post treatment. Pain intensity was assessed at predefined time points (Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Rating Scale (NPRS) where a score of zero indicates "no pain" and "10" indicates "pain as bad as you can imagine". Pain Intensity Differences at each predefined time point (calculated as post-baseline NPRS values - baseline NPRS values) were analyzed. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -50 (indicative of an increase in pain) to 50 (indicative of a decrease in pain).
2 secondary outcomes
Mean Reduction in SPID Scores of DOMS at Rest Over 24 Hours
Time frame: 7 days
Mean Reduction in SPID Scores of DOMS While Standing Over 24 Hours
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Neil Singla, MD principal investigator
Lotus Clinical Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1% diclofenac sodium gel in people with Pain and Delayed Onset Muscle Soreness, run by Lotus Clinical Research, LLC 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 12 inclusion and 13 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 10 Dec 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 10 Dec 2014). 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?
Mean Reduction in SPID Scores of DOMS on Walking Over 24 Hours (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2014.