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Capsaicin Patch 8 % for the Treatment of Persistent Pain After Inguinal Herniotomy

This study is currently recruiting participants.
Verified October 2012 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Joakim Bischoff, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01699854
First received: September 21, 2012
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

In the present study the investigators intend to investigate analgesic and sensory effects of a capsaicin patch 8 %(Qutenza) in patients with severe post-herniotomy pain and sensory abnormalities in the skin.


Condition Intervention Phase
Persistent Pain After Inguinal Herniotomy
 Drug: capsaicin patch (qutenza)
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Capsaicin
U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Pain change capsaicin vs. placebo patch treatment [ Time Frame: Pain intensity assessed at baseline and at 1,2,3 months follow-up ] [ Designated as safety issue: No ]
    Summed pain intensity (SPI) is calculated as median pain intensities at rest, during transition from the supine lying to the standing erect position, and auto-palpation twice each day for the last 3 days at baseline and at 1 months, 2 months and 3 months during follow-up. The primary outcome measure is the maximum difference between the summed pain intensity differences (SPID) for the phases: Baseline, 1 month, 2 month or 3 month. Δ SPID is then calculated as the difference in SPID between capsaicin and placebo treated patients.


Secondary Outcome Measures:
  • Changes in AAS (Activities Assessment Scale) score [ Designated as safety issue: No ]
  • Changes in HADS (Hospital Anxiety and Depression Scale) score [ Designated as safety issue: No ]
  • Changes in QST (Quantitative sensory testing) [ Designated as safety issue: No ]
  • Changes in sleep (Sleep Interference Scale) score [ Designated as safety issue: No ]
  • Changes in S-LANSS (Leeds self-assessment of neuropathic symptoms and signs) [ Designated as safety issue: No ]
  • Changes in intraepidermal nerve fiber density [ Designated as safety issue: No ]
  • Subgroup analysis for pain change(summed pain intensity differences (SPID) capsaicin patch vs. placebo are made for patients with thermal hypoesthesia and thermal normo/hyperesthesia [ Designated as safety issue: No ]
  • Changes in PCS (Pain Catastrophizing Scale) score [ Designated as safety issue: No ]

Other Outcome Measures:
  • interim analyses [ Designated as safety issue: No ]
    An interim analysis evaluating pain change (SPID) for capsaicin patch vs. placebo treatment by an independent statistician following completion of 32 patients.


Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: capsaicin patch Drug: capsaicin patch (qutenza)
Placebo Comparator: placebo patch Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ASA (American Society´s of Anesthesiology´s classification) scores I-III
  • Severe post-herniotomy pain for more than six months and with severe pain (numerical rating scale [NRS] 0-10 points) during rest or during movement > 5.

Exclusion Criteria:

  • History of an allergic reaction or intolerance to capsaicin or vehicle ingredients in the patches
  • Severe cardiac impairment, e.g., NYHA (New York Heart Association) Class ≥ III
  • Inflamed or injured skin at the application site
  • Signs of cognitive impairment
  • Known drug or ethanol abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699854

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Copenhagen Ø, Denmark, 2100
Contact: Joakim Bischoff, MD     35457612        
Principal Investigator: Joakim Bischoff, MD            
Sponsors and Collaborators
Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Joakim Bischoff, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01699854     History of Changes
Other Study ID Numbers: H-4-2012-055, 2012-001540-22
Study First Received: September 21, 2012
Last Updated: October 3, 2012
Health Authority: Denmark: Danish Health and Medicines Authority

Additional relevant MeSH terms:
Capsaicin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013