Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain

NCT ID: NCT02700815

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 746 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-09
• Study Completion Date: 2017-07-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Diclofenac and capsaicin

Fixed dose combination

Group Type: EXPERIMENTAL

Diclofenac

Intervention Type: DRUG

Capsaicin

Intervention Type: DRUG

Diclofenac

Group Type: ACTIVE_COMPARATOR

Diclofenac

Intervention Type: DRUG

Capsaicin

Group Type: ACTIVE_COMPARATOR

Capsaicin

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Diclofenac

Intervention Type: DRUG

Capsaicin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

emovis GMBH, Berlin

Berlin, , Germany

Synexus Clinical Research GmbH

Berlin, , Germany

Synexus Clinical Research GmbH

Bochum, , Germany

Sport- und Präventionsmedizinische Praxis, 50933 Köln

Cologne, , Germany

Dünnwaldpraxis, Köln

Cologne, , Germany

Praxis Dr. Steinebach, Essen

Essen, , Germany

Praxis Dr. Schaefer, 45355 Essen

Essen, , Germany

Unterfrintroper Hausarztzentrum

Essen, , Germany

Synexus Clinical Research GmbH

Frankfurt, , Germany

Praxis Dr. Pabst, Gilching

Gilching, , Germany

Praxis Dr. Dahmen, 22415 Hamburg

Hamburg, , Germany

Praxis Dr. Klein, Künzing

Künzing, , Germany

Synexus Clinical Research GmbH

Leipzig, , Germany

Anästhesiologie Rheinbach

Rheinbach, , Germany

University Clinic of Headache, Private Practice, Moscow

Moscow, , Russia

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

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

Countries

Germany; Russia

References

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.

Reference Type: DERIVED

PMID: 32221866 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

2015-000404-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1358.1

Identifier Type: -

Identifier Source: org_study_id