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

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ClinicalTrials.gov Identifier: NCT01699854
Recruitment Status : Terminated (Expiration of the placebo patch)
First Posted : October 4, 2012
Last Update Posted : February 26, 2014
Sponsor:
Information provided by (Responsible Party):
Joakim Bischoff, Rigshospitalet, Denmark

Brief Summary:
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 or disease Intervention/treatment Phase
Persistent Pain After Inguinal Herniotomy Drug: capsaicin patch (qutenza) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arm Intervention/treatment
Active Comparator: capsaicin patch Drug: capsaicin patch (qutenza)
Placebo Comparator: placebo patch Drug: Placebo



Primary Outcome Measures :
  1. Pain change capsaicin vs. placebo patch treatment [ Time Frame: Pain intensity assessed at baseline and at 1,2,3 months follow-up ]
    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 :
  1. Changes in AAS (Activities Assessment Scale) score
  2. Changes in HADS (Hospital Anxiety and Depression Scale) score
  3. Changes in QST (Quantitative sensory testing)
  4. Changes in sleep (Sleep Interference Scale) score
  5. Changes in S-LANSS (Leeds self-assessment of neuropathic symptoms and signs)
  6. Changes in intraepidermal nerve fiber density
  7. 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
  8. Changes in PCS (Pain Catastrophizing Scale) score

Other Outcome Measures:
  1. interim analyses
    An interim analysis evaluating pain change (SPID) for capsaicin patch vs. placebo treatment by an independent statistician following completion of 32 patients.



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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:

  • 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

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): NCT01699854


Locations
Denmark
Rigshospitalet
Copenhagen, Copenhagen Ø, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ( EudraCT Number )
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: February 26, 2014
Last Verified: February 2014

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