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Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain

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ClinicalTrials.gov Identifier: NCT02700815
Recruitment Status : Completed
First Posted : March 7, 2016
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Acute Pain Drug: Diclofenac Drug: Capsaicin Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 746 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Multi-centre Parallel Group Study to Assess the Efficacy and Safety of Multiple Doses of a Topically Applied Combination Containing Diclofenac 2% + Capsaicin 0.075% (2 g Formulation Per Application; 2-times Daily for 5 Days) Compared to Placebo, as Well as to Diclofenac 2% and Capsaicin 0.075% in Patients With Acute Back or Neck Pain
Actual Study Start Date : May 9, 2016
Actual Primary Completion Date : July 13, 2017
Actual Study Completion Date : July 21, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diclofenac and capsaicin
Fixed dose combination
Drug: Diclofenac
Drug: Capsaicin
Active Comparator: Diclofenac Drug: Diclofenac
Active Comparator: Capsaicin Drug: Capsaicin
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Change in pain on movement (POM) between baseline and Day 2 evening, 1 hour after drug application with regard to the POM of the procedure which gave the highest score at baseline (pain on movement of worst procedure, POM-WP) [ Time Frame: 36 hours ]

Secondary Outcome Measures :
  1. Area under the curve of POM-WP assessed until Day 6 morning, i.e. 120 hours after start of treatment [ Time Frame: 120 hours ]
  2. Number of patients with a decrease in POM-WP of at least 30% from baseline on Day 2 evening, 1 hour after drug application [ Time Frame: 36 hours ]
  3. Number of patients with a decrease in POM-WP of at least 50% from baseline on Day 2 evening, 1 hour after drug application [ Time Frame: 36 hours ]
  4. Change in POM-WP between baseline and the morning of Day 6 [ Time Frame: 120 hours ]
  5. Change in Pressure Algometry (PA) between baseline and Day 2 evening, before drug application [ Time Frame: 36 hours ]
  6. Change in PA between baseline and the morning of Day 6 [ Time Frame: 120 hours ]
  7. Area under the curve of POM-WP assessed until Day 4 morning, i.e. 72 hours after start of treatment [ Time Frame: 72 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700815


Locations
Germany
emovis GMBH, Berlin
Berlin, Germany, 10629
Synexus Clinical Research GmbH
Berlin, Germany, 12627
Synexus Clinical Research GmbH
Bochum, Germany, 44787
Praxis Dr. Steinebach, Essen
Essen, Germany, 45277
Praxis Dr. Schaefer, 45355 Essen
Essen, Germany, 45355
Unterfrintroper Hausarztzentrum
Essen, Germany, 45359
Synexus Clinical Research GmbH
Frankfurt, Germany, 60313
Praxis Dr. Pabst, Gilching
Gilching, Germany, 82205
Praxis Dr. Dahmen, 22415 Hamburg
Hamburg, Germany, 22415
Sport- und Präventionsmedizinische Praxis, 50933 Köln
Köln, Germany, 50933
Dünnwaldpraxis, Köln
Köln, Germany, 51069
Praxis Dr. Klein, Künzing
Künzing, Germany, 94550
Synexus Clinical Research GmbH
Leipzig, Germany, 04103
Anästhesiologie Rheinbach
Rheinbach, Germany, 53359
Russian Federation
University Clinic of Headache, Private Practice, Moscow
Moscow, Russian Federation, 129090
State Budget.Hlthcare Inst.City Outpatient dept #123,Therapy
St. Petersburg, Russian Federation, 192289
Medical Centre "Reavita", Therapy Dept., St. Petersburg
St. Petersburg, Russian Federation, 194325
St.Petersburg State Budget.Hlthcare Inst.City Outpat.dep#107
St. Petersburg, Russian Federation, 195030
Consutative-Diagn.Cntre w/ Polyclin.Dept.Pres.Affairs,Neurol
St. Petersburg, Russian Federation, 197110
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02700815     History of Changes
Other Study ID Numbers: 1358.1
2015-000404-25 ( EudraCT Number )
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Neck Pain
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Diclofenac
Capsaicin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents