Voltaren Emulgel 2% Acute Ankle Sprain Non Inferiority Study

NCT04052620 | Completed Phase 3 Results

• 2 other identifiers: 2112062016L09875
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 14

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of diclofenac diethylamine 2.32 percent (%) gel applied twice daily versus diclofenac diethylamine 1.16% gel applied four times daily for 7 days in participants with acute ankle sprain.

Conditions

Pain

Keywords

Ankle sprain; diclofenac diethylamine

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pain on Movement (POM) on Day 5 of Treatment as Assessed by a 100 Millimeter (mm) Visual Analogue Scale (VAS)

  The investigator performed a movement of the ankle and the pain assessment was done by the participant using a 100 mm VAS by describing ankle pain on movement. The POM was registered by the participant by drawing a perpendicular line on the 100 mm VAS with anchors at 0 = no pain and 100 = extreme pain. Higher scores indicate a worse outcome. Change from Baseline in POM was calculated by subtracting the Baseline value from the Day 5 value.

  Baseline and Day 5

Secondary Outcomes (11)

• Number of Participants With Severity of Adverse Events (AEs) Following Dosing With Study Medication

  up to 28 days following last administration of the study product (or last procedure)

• Change From Baseline of POM on VAS on Day 3 and Day 8 of Treatment Assessed by 100 mm VAS

  Baseline and Days 3 and 8

• Change From Baseline in Tenderness as Measured by Pressure Algometry on Days 3, 5 and 8

  Baseline and Days 3, 5 and 8

• Changes From Baseline in Difference of Tenderness Between Affected Ankle and Contralateral Ankle Measured by Algometry on Days 3, 5 and 8

  Baseline and Days 3, 5 and 8

• Change From Baseline in Ankle Joint Function (Karlsson Scoring Scale) on Days 3, 5 and 8

  Baseline and Days 3, 5 and 8

Study Arms (2)

Diclofenac diethylamine (DDEA) 2.32%/ Placebo gel

EXPERIMENTAL

Participants will receive 4 tubes, DDEA 2.32% gel and Placebo gel (2 each) and instructed to apply the gel 5 centimeter (cm) topically with the finger tips (for approximately 1 minute) on both sides of affected ankle on area of approximately 200 square centimeters (cm\^2). DDEA 2.32% gel will be applied in morning and late afternoon and Placebo gel will be applied in noon and late evening for 7 days.

Drug: Diclofenac diethylamine 2.32% gel; Other: Placebo

DDEA 1.16% gel

ACTIVE COMPARATOR

Participants will receive 4 tubes of DDEA 1.16% gel and instructed to apply the gel 5 centimeter (cm) topically with the finger tips (for approximately 1 minute) on both sides of affected ankle on area of approximately 200 square centimeters (cm\^2) in morning, noon, late afternoon, and late evening for 7 days.

Drug: Diclofenac diethylamine 1.16% gel

Interventions

Diclofenac diethylamine 2.32% gel DRUG

Participants will apply DDEA 2.32% gel topically with the finger tips (for approximately 1 minute) on both sides of affected ankle 5 cm on 200 cm\^2 two times daily for 7 days.

Diclofenac diethylamine (DDEA) 2.32%/ Placebo gel

Diclofenac diethylamine 1.16% gel DRUG

Participants will apply DDEA 1.16 % gel topically with the finger tips (for approximately 1 minute) on both sides of affected ankle 5 cm on 200 cm\^2 four times daily for 7 days.

DDEA 1.16% gel

Placebo OTHER

Participants will apply Placebo gel topically with the finger tips (for approximately 1 minute) on both sides of affected ankle 5 cm on 200 cm\^2 two times daily for 7 days.

Diclofenac diethylamine (DDEA) 2.32%/ Placebo gel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment will be performed.
• A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures.
• A participant with acute sprain of the lateral ankle on one side only, Grade I-II.
• A participant who had pain-on-movement greater than or equal to (\>=) 50 mm on a 100 mm VAS.
• A participant with injury within the past 24 hours before randomization.
• Participant had not taken pain medication within the 24 hours that precedes randomization.Treatment by rest, ice, compression, or elevation (RICE) is authorized prior to randomization. Stable daily doses of acetylsalicylic acid (less than or equal to \[\<=\] 162 mg) taken for at least 30 days prior to the first dose of study medication for non-analgesic reasons may be continued for the duration of the study.
• A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee with no clinically significant/relevant abnormalities in medical history or upon physical examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
• Female participant of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for 14 days after the last dose of assigned treatment.

You may not qualify if:

• A participant with Grade I-III sprain of the affected ankle during the past 3 months.
• A participant with Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the affected ankle or foot during the past 6 months.
• A participant with pain or instability in the affected ankle attributable to previous ankle sprain or any other trauma.
• A participant with ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue diseases (e.g. Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).
• A participant who has any skin lesion or wound in the area to be treated.
• A participant who intent to undergo surgery during time of participation.
• A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family.
• A participant with,in the opinion of the investigator or medically qualified designee, an acute or chronic medical, including other current acute or chronic pain conditions, or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
• A participant who is a pregnant female.
• A participant who is a breastfeeding female.
• A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
• A participant unwilling or unable to comply with the Lifestyle Considerations below: a) No special requirement for food and drink prior to safety laboratory evaluations. b) Participants will abstain from caffeine-containing products for 12 hours prior to study visit days (except screening/randomization visit). c) Participants will abstain from strenuous exercise (e.g. heavy lifting, weight training, calisthenics, aerobics) for the duration of the study. Walking at a normal pace will be permitted.
• A participant who has made use of prescription, non-prescription, or dietary supplements, containing NSAIDs, COX-2 inhibitors and other analgesic treatments within 7 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product and during the study.
• A participant with topical analgesics or anti-inflammatory treatment over the previous 30 days in the area to be treated in the study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (14)

GSK Investigational Site

Guangzhou, Guangdong, 510630, China

Location

GSK Investigational Site

Shenzhen, Guangdong, 100730, China

Location

GSK Investigational Site

Shenzhen, Guangdong, 518053, China

Location

GSK Investigational Site

Shijiazhuang, Hebei, 050051, China

Location

GSK Investigational Site

Chenzhou, Hunan, 423000, China

Location

GSK Investigational Site

Dalian, Liaoning, 116001, China

Location

GSK Investigational Site

Shenyang, Liaoning, 110044, China

Location

GSK Investigational Site

Xi'an, Shaanxi, 710061, China

Location

GSK Investigational Site

Kunming, Yunnan, 650032, China

Location

GSK Investigational Site

Beijing, 101200, China

Location

GSK Investigational Site

Shanghai, 200025, China

Location

GSK Investigational Site

Shanghai, 200080, China

Location

GSK Investigational Site

Shanghai, 200120, China

Location

GSK Investigational Site

Shanghai, 201449, China

Location

Related Publications (1)

• Yin F, Ma J, Xiao H, Ao R, Zhang F, Li W, Wang W, Zeng P, Lu T, Revel FB, Araga M, Patel S, Moreira S, Zhang J, Zhang W. Randomized, double-blind, noninferiority study of diclofenac diethylamine 2.32% gel applied twice daily versus diclofenac diethylamine 1.16% gel applied four times daily in patients with acute ankle sprain. BMC Musculoskelet Disord. 2022 Dec 24;23(1):1125. doi: 10.1186/s12891-022-06077-z.

  PMID: 36566202 DERIVED

MeSH Terms

Conditions

Pain; Ankle Injuries

Interventions

diclofenac diethylamine; Gels

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

8664357343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: August 12, 2019
• Study Start: October 24, 2019
• Primary Completion: November 12, 2020
• Study Completion: November 12, 2020
• Last Updated: April 12, 2022
• Results First Posted: April 12, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be grated, when justified, for up to another 12 months.

Locations

CN (14)