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

NCT01699854 | Terminated Phase 3 DMC

• 2 other identifiers: H-4-2012-0552012-001540-22
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Persistent Pain After Inguinal Herniotomy

Outcome Measures

Primary Outcomes (1)

• Pain change capsaicin vs. placebo patch treatment

  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.

  Pain intensity assessed at baseline and at 1,2,3 months follow-up

Secondary Outcomes (8)

• Changes in AAS (Activities Assessment Scale) score

• Changes in HADS (Hospital Anxiety and Depression Scale) score

• Changes in QST (Quantitative sensory testing)

• Changes in sleep (Sleep Interference Scale) score

• Changes in S-LANSS (Leeds self-assessment of neuropathic symptoms and signs)

Other Outcomes (1)

• interim analyses

Study Arms (2)

capsaicin patch

ACTIVE COMPARATOR

Drug: capsaicin patch (qutenza)

placebo patch

PLACEBO COMPARATOR

Drug: Placebo

Interventions

capsaicin patch (qutenza) DRUG

capsaicin patch

Placebo DRUG

placebo patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Copenhagen Ø, 2100, Denmark

Location

Related Publications (1)

• Bischoff JM, Ringsted TK, Petersen M, Sommer C, Uceyler N, Werner MU. A capsaicin (8%) patch in the treatment of severe persistent inguinal postherniorrhaphy pain: a randomized, double-blind, placebo-controlled trial. PLoS One. 2014 Oct 7;9(10):e109144. doi: 10.1371/journal.pone.0109144. eCollection 2014.

  PMID: 25290151 DERIVED

MeSH Terms

Interventions

Capsaicin

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: October 4, 2012
• Study Start: August 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 26, 2014

Record last verified: 2014-02

Locations

DK (1)