Fissure;AnalPhase 4NCT02961855
Efficacy and Safety of CLIFE1 Gel in Benign Anorectal Surgery
A Phase 4 study testing anesthesics plus antiinflammatory, CLIFE1 and local anesthesics, CLIFE2 in people with Fissure;Anal and Fistula;Rectal, run by Hospital de Viladecans.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fissure;Anal, Fistula;Rectal, Hemorrhoids
- What is being tested?
- anesthesics plus antiinflammatory, CLIFE1 and local anesthesics, CLIFE2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing benign anorectal surgery (out or inpatients), with the following diagnoses: anal fissure, fistula, hemorrhoids
- Use of subarachnoid anesthesia with lidocaine
Who cannot join
- 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
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- 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
About this study
Official title: Double-blinded Multicenter Randomized Clinical Trial to Evaluate the Efficacy and Safety of CLIFE1 and CLIFE2 Gels in Benign Anorectal Surgery
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.
Read the detailed description
120 patients were randomly assigned to two groups (60 in each group). The study was conducted in two parallel groups, with 1:1 randomization stratified by type of surgery and centre.
Treatment with CLIFE 1 and CLIFE 2 was applied from day 1 to day 6 post-surgery
- Conditions
- Fissure;Anal, Fistula;Rectal, Hemorrhoids
- Being tested
- anesthesics plus antiinflammatory, CLIFE1, local anesthesics, CLIFE2
- Medical subject headings
- Fissure in Ano, Rectal Fistula, Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesics plus antiinflammatory, CLIFE1Drug
Also called lidocaine plus diclofenac, CLIFE1 topical gel
anesthesics plus antiinflammatory, CLIFE1 topical gel containing lidocaine plus diclofenac anesthesics plus antiinflammatory
local anesthesics, CLIFE2Drug
Also called lidocaine, CLEFE2 topical gel
local anesthesics, CLIFE2 topical gel containing lidocaine local anesthesics
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: local anesthesics, CLIFE2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean level of pain, as assessed by visual analog scale (VAS)
Measured: 3 days post-surgery
Secondary outcomes (8)
Mean level of pain (VAS) at day 3 post-surgery
Measured: 6 days post-surgery
Level of pain (VAS), assessed by Andersen scale
Measured: 6 days post-surgery
Pain relief
Question about pain relief in comparison with the last application (scores from 0 to 4).
Measured: 6 days post-surgery
analgesics use
Measured: 6 days post-surgery
patient satisfaction
Satisfaction questionnaire about the efficacy of treatment (6 levels)
Measured: 6 days post-surgery
demographic and clinical characteristics-1
sex
Measured: baseline
demographic and clinical characteristics-2
age
Measured: baseline
safety evaluation as assessed by recording fo adverse events
recording of adverse events
Measured: 6 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fissure;AnalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Viladecans
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María José Linares Gil, Hospital de Viladecans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961855
- Sponsor's protocol ID
- CLIFE-01FV
- Status last verified
- Nov 2016
- First submitted
- 27 Sep 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blinded Multicenter Randomized Clinical Trial to Evaluate the Efficacy and Safety of CLIFE1 and CLIFE2 Gels in Benign Anorectal Surgery
- ClinicalTrials.gov ID
- NCT02961855
- Acronym / sponsor ID
- CLIFE-01FV
- Conditions
- Fissure;Anal, Fistula;Rectal, Hemorrhoids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospital de ViladecansUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
120 patients were randomly assigned to two groups (60 in each group). The study was conducted in two parallel groups, with 1:1 randomization stratified by type of surgery and centre.
Treatment with CLIFE 1 and CLIFE 2 was applied from day 1 to day 6 post-surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clife1 gel (lidocaine plus diclofenac) | Experimental | Drug: anesthesics plus antiinflammatory, CLIFE1Clife1 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 |
| Clife2 gel (lidocaine) | Active comparator | Drug: local anesthesics, CLIFE2Clife2 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing benign anorectal surgery (out or inpatients), with the following diagnoses: anal fissure, fistula, hemorrhoids
- Use of subarachnoid anesthesia with lidocaine
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anesthesics plus antiinflammatory, CLIFE1Also: lidocaine plus diclofenac, CLIFE1 topical gelanesthesics plus antiinflammatory, CLIFE1 topical gel containing lidocaine plus diclofenac anesthesics plus antiinflammatory | Drug | Clife1 gel (lidocaine plus diclofenac) |
| local anesthesics, CLIFE2Also: lidocaine, CLEFE2 topical gellocal anesthesics, CLIFE2 topical gel containing lidocaine local anesthesics | Drug | Clife2 gel (lidocaine) |
Primary outcome
mean level of pain, as assessed by visual analog scale (VAS)
Time frame: 3 days post-surgery
8 secondary outcomes
Mean level of pain (VAS) at day 3 post-surgery
Time frame: 6 days post-surgery
Level of pain (VAS), assessed by Andersen scale
Time frame: 6 days post-surgery
Pain relief
Time frame: 6 days post-surgery
analgesics use
Time frame: 6 days post-surgery
patient satisfaction
Time frame: 6 days post-surgery
demographic and clinical characteristics-1
Time frame: baseline
demographic and clinical characteristics-2
Time frame: baseline
safety evaluation as assessed by recording fo adverse events
Time frame: 6 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing anesthesics plus antiinflammatory, CLIFE1 and local anesthesics, CLIFE2 in people with Fissure;Anal and Fistula;Rectal, run by Hospital de Viladecans.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean level of pain, as assessed by visual analog scale (VAS) (time frame: 3 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.