NCT02961855

Brief Summary

Double-blinded multicenter randomized clinical trial to evaluate the efficacy and safety of CLIFE2 (lidocaine, referred as treatment A) respect CLIFE1 (lidocaine plus diclofenac, referred as treatment B) in benign anorectal surgery.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2011

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
Last Updated

November 15, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

September 27, 2016

Last Update Submit

November 14, 2016

Conditions

Fissure;AnalFistula;RectalHemorrhoids

Outcome Measures

Primary Outcomes (1)

  • mean level of pain, as assessed by visual analog scale (VAS)

    3 days post-surgery

Secondary Outcomes (8)

  • Mean level of pain (VAS) at day 3 post-surgery

    6 days post-surgery

  • Level of pain (VAS), assessed by Andersen scale

    6 days post-surgery

  • Pain relief

    6 days post-surgery

  • analgesics use

    6 days post-surgery

  • patient satisfaction

    6 days post-surgery

  • +3 more secondary outcomes

Study Arms (2)

Clife1 gel (lidocaine plus diclofenac)

EXPERIMENTAL

Clife1 gel (lidocaine plus diclofenac) Topical gel containing lidocaine (2%) plus diclofenac (0.5%) (15 g in total) Application of the gel bid from first day post-surgery to day 3 and once daily from day 4 to day 6

Drug: anesthesics plus antiinflammatory, CLIFE1

Clife2 gel (lidocaine)

ACTIVE COMPARATOR

Clife2 gel (lidocaine) Topical gel containing lidocaine (2%) (15 g in total) Application of the gel bid from first day post-surgery to day 3 and once daily from day 4 to day 6

Drug: local anesthesics, CLIFE2

Interventions

anesthesics plus antiinflammatory, CLIFE1DRUG

anesthesics plus antiinflammatory, CLIFE1 topical gel containing lidocaine plus diclofenac anesthesics plus antiinflammatory

Also known as: lidocaine plus diclofenac, CLIFE1 topical gel
Clife1 gel (lidocaine plus diclofenac)
local anesthesics, CLIFE2DRUG

local anesthesics, CLIFE2 topical gel containing lidocaine local anesthesics

Also known as: lidocaine, CLEFE2 topical gel
Clife2 gel (lidocaine)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing benign anorectal surgery (out or inpatients), with the following diagnoses: anal fissure, fistula, hemorrhoids
  • Use of subarachnoid anesthesia with lidocaine

You may not qualify if:

  • Allergy or Hypersensitivity to lidocaine or other local anesthesics.
  • Patients not accepting subarachnoid anesthesia
  • Patients with general anesthesia
  • Hypersensitivity or contraindication to acetylsalicylic acid.
  • History of gastrointestinal hemorrhage or perforation due to nonsteroidal anti-inflammatory drugs (NSAIDs) use
  • Active or relapsing peptic ulcer/gastrointestinal hemorrhage
  • Serious heart failure.
  • Active Crohn disease
  • Active ulcerative colitis
  • Moderate or sever renal failure
  • Severe liver disfunction
  • Coagulation disorders requiring treatment with anticoagulant drugs
  • Proctitis (due to autoimmune disease, foreign substances, sucally transmitted diseases
  • Treatment with: Beta blockers, calcium channel blockers (verapamil and diltiazem), anti-arrhythmics (digoxin, amiodarone), ivabradine, lithium, steroids
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fissure in AnoRectal FistulaHemorrhoids

Interventions

Anti-Inflammatory AgentsLidocaineDiclofenac

Condition Hierarchy (Ancestors)

Anus DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesIntestinal FistulaDigestive System FistulaFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutic UsesPharmacologic ActionsChemical Actions and UsesAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylacetatesAcids, CarbocyclicCarboxylic Acids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 27, 2016

First Posted

November 11, 2016

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Study Completion

December 1, 2013

Last Updated

November 15, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share