Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain

NCT02700815 | Completed Phase 3 Results

• 2 other identifiers: 1358.12015-000404-25
• Study Type: interventional
• Target: 746
• Locations: 2 countries
• Sites: 18

Brief Summary

This randomised, controlled multi-centre parallel group trial will assess the efficacy and tolerability of a topical formulation gel of the combination of diclofenac and capsaicin in comparison to gels with diclofenac alone, capsaicin alone, and placebo for the treatment of acute back pain or neck pain

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Change in POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application

  Pain on movement (POM) was used to assess pain measurement for back and neck pain. The standardized movements have been established for which the measurement was taken. POMwp was the POM measure that gave the highest score at baseline; i.e. POM of worst procedure. Pain intensity was assessed at rest after standing in an upright position relatively motionless for 1 minute. The pain was evaluated by asking patient 'How would you rate your pain right now?' and by using a visual analogue scale (VAS) ranging from 0-10 centimeters (cm) wherein 0 cm = no pain to 10 cm = worst pain possible. The results presented here are adjusted mean change from baseline and standard error for POMwp in cm.

  Baseline and Day 2

Secondary Outcomes (7)

• POMwp Area Under the Curve (AUC) Calculated From 0 to 72 Hours (h) (POMwp AUC(0-72 h))

  0 to 72 hours after start of treatment

• POMwp Area Under the Curve (AUC) Calculated From 0 to 120 Hours (h) (POMwp AUC(0-120 h))

  0 to 120 hours after start of treatment

• Number of Patients With Decrease in POMwp of at Least 30% From Baseline

  Baseline and day 2

• Number of Patients With Decrease in POMwp of at Least 50% From Baseline

  Baseline and day 2

• Change From Baseline in POMwp (cm) at Day 6 Morning

  Baseline and Day 6

Study Arms (4)

Diclofenac and capsaicin

EXPERIMENTAL

Fixed dose combination

Drug: Diclofenac; Drug: Capsaicin

Diclofenac

ACTIVE COMPARATOR

Drug: Diclofenac

Capsaicin

ACTIVE COMPARATOR

Drug: Capsaicin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Diclofenac DRUG

Diclofenac; Diclofenac and capsaicin

Capsaicin DRUG

Capsaicin; Diclofenac and capsaicin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written informed consent at Visit 1 in accordance with Good Clinical Practice and local legislation
• Male or female patients \>=18 years with current diagnosis of acute back pain or of neck pain for at least 24 hours, but less than 21 days
• Acute back pain or acute neck pain resulting in pain on movement (POM) \>= 50 mm (Visual Analogue Scale 0-100) for at least one POM procedure out of 5 standardized procedures.
• Sensitivity to algometric pressure on the painful trigger point \<= 25 N/cm2
• Women of childbearing potential must be ready and able to use highly effective methods of birth control

You may not qualify if:

• History of 3 or more episodes of back or neck pain in the last 6 months excluding the current episode
• Surgery due to back or neck pain or rehabilitation due to back or neck pain in the last 12 months
• Back or neck pain that is attributable to any specific identifiable cause (e.g. disc prolapse, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological diseases or tumour)
• Trauma or strains of the back or neck muscles within the last 3 months
• Prior use within the last 3 days before Visit 1 or concomitant use of any anti-inflammatory drugs, heparinoids, muscle relaxants or analgesics. Long-acting glucocorticoids must have been discontinued 10 days before study entry. Spinal injections should have been discontinued in due time (investigator's judgement) before patient enrolment to allow complete wash-out of the active ingredient based on investigator's judgment
• Non-pharmacological treatment (physiotherapy, heat treatment (e.g. heat patch, hot water bottle), or massage, acupuncture, transcutaneous electrical nerve stimulation) or locally applied pharmacological product to the back or neck area 24 hours prior study entry and during the study period
• Known severe hepatocellular insufficiency, severe renal insufficiency or Gilbert's syndrome (Morbus Meulengracht)
• Any other medical condition that would interfere with efficacy and safety assessments based on investigator's judgement or any on-going clinical condition that would jeopardize patient's or site personnel's safety or study compliance based on investigator judgement.
• Known intolerance or hypersensitivity to the active ingredients or any excipient(s).
• Patients in whom attacks of asthma, bronchospasm, rhinitis or urticaria were precipitated by the intake of Acetyl salicylic acid (ASS) or other NSAIDs
• Irritated skin (based on investigator's judgement), skin wounds, eczema or open injuries at application site
• Negative experience in the past with heat treatments for muscle complaints
• Patient not able to understand and comply with trial requirements based on investigators judgement
• Alcohol or drug abuse
• Participation in a clinical trial within the previous 30 days or simultaneous participation in another clinical trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (18)

emovis GMBH, Berlin

Berlin, 10629, Germany

Location

Synexus Clinical Research GmbH

Berlin, 12627, Germany

Location

Synexus Clinical Research GmbH

Bochum, 44787, Germany

Location

Sport- und Präventionsmedizinische Praxis, 50933 Köln

Cologne, 50933, Germany

Location

Dünnwaldpraxis, Köln

Cologne, 51069, Germany

Location

Praxis Dr. Steinebach, Essen

Essen, 45277, Germany

Location

Praxis Dr. Schaefer, 45355 Essen

Essen, 45355, Germany

Location

Unterfrintroper Hausarztzentrum

Essen, 45359, Germany

Location

Synexus Clinical Research GmbH

Frankfurt, 60313, Germany

Location

Praxis Dr. Pabst, Gilching

Gilching, 82205, Germany

Location

Praxis Dr. Dahmen, 22415 Hamburg

Hamburg, 22415, Germany

Location

Praxis Dr. Klein, Künzing

Künzing, 94550, Germany

Location

Synexus Clinical Research GmbH

Leipzig, 04103, Germany

Location

Anästhesiologie Rheinbach

Rheinbach, 53359, Germany

Location

University Clinic of Headache, Private Practice, Moscow

Moscow, 129090, Russia

Location

State Budget.Hlthcare Inst.City Outpatient dept #123,Therapy

Saint Petersburg, 192289, Russia

Location

Medical Centre "Reavita", Therapy Dept., St. Petersburg

Saint Petersburg, 194325, Russia

Location

St.Petersburg State Budget.Hlthcare Inst.City Outpat.dep#107

Saint Petersburg, 195030, Russia

Location

Related Publications (1)

• Predel HG, Ebel-Bitoun C, Peil B, Weiser TW, Lange R. Efficacy and Safety of Diclofenac + Capsaicin Gel in Patients with Acute Back/Neck Pain: A Multicenter Randomized Controlled Study. Pain Ther. 2020 Jun;9(1):279-296. doi: 10.1007/s40122-020-00161-9. Epub 2020 Mar 27.

  PMID: 32221866 DERIVED

MeSH Terms

Conditions

Acute Pain

Interventions

Diclofenac; Capsaicin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Polyunsaturated Alkamides; Amides; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Limitations and Caveats

A possible limitation of this study design related to the warming effect that is attributable to the topical application of capsaicin, which could potentially have led to inadvertent unblinding of treatment assignments in the study.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 7, 2016
• Study Start: May 9, 2016
• Primary Completion: July 13, 2017
• Study Completion: July 21, 2017
• Last Updated: May 6, 2019
• Results First Posted: May 6, 2019

Record last verified: 2019-02

Locations

DE (14); RU (4)