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

This study has been terminated.
(Expiration of the placebo patch)
Sponsor:
Information provided by (Responsible Party):
Joakim Bischoff, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01699854
First received: September 21, 2012
Last updated: February 25, 2014
Last verified: February 2014
  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:


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
Study Completion Date: September 2013
Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699854

Locations
Denmark
Rigshospitalet
Copenhagen, Copenhagen Ø, Denmark, 2100
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: February 25, 2014
Health Authority: Denmark: Danish Health and Medicines Authority

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

ClinicalTrials.gov processed this record on October 30, 2014