HemorrhoidsPhase 2Hydro/LidoNCT02689856
Safety and Efficacy of Hydrocortisone and Lidocaine Treatment of Grade I and II Hemorrhoids
A Phase 2 study testing Hydrocortisone acetate and lidocaine hydrochloride, Hydrocortisone acetate and Lidocaine hydrochloride in people with Hemorrhoids, run by Citius Pharmaceuticals, Inc..
Trial summary
The objectives of this study are to assess the potential contribution of lidocaine hydrochloride or hydrocortisone acetate, alone or in combination, in topical cream preparations in the treatment of Grade I or II hemorrhoids and to demonstrate the safety and efficacy of the test articles when applied twice daily for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Hydrocortisone acetate and lidocaine hydrochloride, Hydrocortisone acetate and Lidocaine hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Oct 2015
- Phase
- Phase 2
- 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
- Subject is male or non-pregnant female 18 years of age or older, in generally good health. Females must be post-menopausal, surgically sterile or have a negative urine pregnancy test (UPT) at the Baseline Visit and agree to use birth control during the study.
- Subject has provided written and verbal informed consent.
- Subject presents to the clinic with clinically confirmed symptomatic Grade I or II hemorrhoids (GSDS ≥ 2).
- Subject is willing and able to comply with study instructions and return to the clinic for required visits.
Who cannot join
- Subject is female and lactating or planning to become pregnant during the study.
- Subject has anorectal condition(s) such as malignant tumors of the anus or rectum, fistula-in-ano or chronic sepsis, fissure-in-ano, incontinence, condylomata and Grade III and IV hemorrhoids.
- Subject has a history of previous proctological surgery or has active inflammatory bowel disease.
- Subject may use stool softeners, but shall be on a stable regimen for at least 28 days prior to enrolling in the study.
- Subject used the following systemic, oral or topical therapies for the periods specified prior to entry into the study:
- Within 1 day: Topicals of any kind to the rectal/peri-rectal area.
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- Within 1 week: Over the counter (OTC) or prescription treatments labeled or intended for the treatment of hemorrhoids or that could have a significant effect in the opinion of the investigator including but not limited to steroids, OTC and prescription hemorrhoid products, among others.
- Subject has a current history of an uncorrected coagulation defect or concurrently uses anticoagulants (except aspirin or non-steroidals).
- Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical, systemic or surgical therapy.
- Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
- Subject has any condition which, in the Investigator's opinion, would make it unsafe or preclude the subject's ability to fully participate in this research study.
- Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, impaired cerebral function or physical limitations.
- Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
- Subject is currently enrolled in an investigational drug or device study.
- Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline).
About this study
Official title: A Randomized, Dose-Ranging, Double Blind Study of Lidocaine Hydrochloride and/or Hydrocortisone Acetate (Alone or in Combination) in the 14-Day Twice-Daily Treatment of Grade I or II Hemorrhoids
The objectives of this study are to assess the potential contribution of lidocaine hydrochloride or hydrocortisone acetate, alone or in combination, in topical cream preparations in the treatment of Grade I or II hemorrhoids and to demonstrate the safety and efficacy of the test articles when applied twice daily for 14 days in subjects with Grade I or II hemorrhoids. These products reflect common drug combinations of lidocaine hydrochloride or hydrocortisone acetate found in many prescription hemorrhoid products.
Read the detailed description
This is a multi-center, randomized, double-blind, parallel group comparison study in approximately 196 enrolled subjects (~28 subjects/test article) at approximately eight (8) sites. A minimum of 147 patients will be enrolled. Up to an additional 56 subjects (up to 196 subjects) may be enrolled based on enrollment rates and availability of patients. Enrollment status reports will be periodically generated, and based on enrollment experience, additional randomization blocks will be assigned to sites with the potential to enroll additional subjects over a reasonable period of time.
Male and female subjects, ages 18 years and older, with a clinical diagnosis of symptomatic Grade I or Grade II hemorrhoids will be randomized to treatment with one of seven (7) test articles (1:1 for all groups):
- Vehicle Cream
- 3% Hydrocortisone Acetate Cream
- 0.5% Hydrocortisone Acetate Cream
- 5% Lidocaine Hydrochloride Cream
- 1% Lidocaine Hydrochloride Cream
- 3% Hydrocortisone Acetate Cream and 5% Lidocaine Hydrochloride Cream
- 0.5% Hydrocortisone Acetate Cream and 1% Lidocaine Hydrochloride Cream
The test articles will be applied twice daily for two (2) weeks (14 days) to the peri-rectal area as well as the distal aspect of the anal canal using the product applicator tip.
- Conditions
- Hemorrhoids
- Being tested
- Hydrocortisone acetate and lidocaine hydrochloride, Placebo control, Hydrocortisone acetate, Lidocaine hydrochloride
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone acetate and lidocaine hydrochlorideDrug
Hydrocortisone and lidocaine in combination
Placebo controlDrug
Vehicle cream alone
Hydrocortisone acetateDrug
hydrocortisone alone
Lidocaine hydrochlorideDrug
lidocaine alone
| Study group | Role | What they receive |
|---|---|---|
| Vehicle cream | Placebo comparator | Placebo control base cream Receives: Drug: Placebo control |
| 3% hydrocortisone | Experimental | 3% Hydrocortisone acetate cream Receives: Drug: Hydrocortisone acetate |
| 0.5% hydrocortisone | Experimental | 0.5% Hydrocortisone acetate cream Receives: Drug: Hydrocortisone acetate |
| 5% lidocaine | Experimental | 5% Lidocaine hydrochloride cream Receives: Drug: Lidocaine hydrochloride |
| 1% lidocaine | Experimental | 1% Lidocaine hydrochloride cream Receives: Drug: Lidocaine hydrochloride |
| 3% Hydro 5% Lido | Experimental | Hydrocortisone acetate and lidocaine hydrochloride at 3% and 5% cream Receives: Drug: Hydrocortisone acetate and lidocaine hydrochloride |
| 0.5% Hydro 1% Lido | Experimental | Hydrocortisone acetate and lidocaine hydrochloride at 0.5% and 1% cream Receives: Drug: Hydrocortisone acetate and lidocaine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global score of disease severity
A measure overall discomfort on a scale of 0 to 5
Measured: up to 14 days
Secondary outcomes (6)
Individual signs and symptoms
Has the subject received relief of pain, itching, bleeding or other reported symptoms evaluated on a scale of 0 to 5.
Measured: up to 14 days
Onset of relief of symptoms
How fast does the subject feel relief of symptoms measured in time after application of the drug.
Measured: 4 hours following product administration
Recurrence of symptoms
When do the symptoms return measured in time after application of the drug.
Measured: 4 hours following product administration
Severity and frequency of adverse events
Assessment of severity and frequency of adverse events.
Measured: 14 days
Laboratory assessment
Assessment of changes in blood chemistry, hematology and urinalysis at day 14 compared to baseline.
Measured: 14 days
Electrocardiography
Assessment of changes in ECG parameters at day 14 compared to baseline.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startMay 2015
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Citius Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan S. Lader, Ph.D., Study director, Citius Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689856
- Sponsor's protocol ID
- 143-6151-201
- Acronym
- Hydro/Lido
- Status last verified
- Feb 2016
- First submitted
- 17 Feb 2016
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Dose-Ranging, Double Blind Study of Lidocaine Hydrochloride and/or Hydrocortisone Acetate (Alone or in Combination) in the 14-Day Twice-Daily Treatment of Grade I or II Hemorrhoids
- ClinicalTrials.gov ID
- NCT02689856
- Acronym / sponsor ID
- Hydro/Lido / 143-6151-201
- Conditions
- Hemorrhoids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Citius Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 24 Feb 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.
The objectives of this study are to assess the potential contribution of lidocaine hydrochloride or hydrocortisone acetate, alone or in combination, in topical cream preparations in the treatment of Grade I or II hemorrhoids and to demonstrate the safety and efficacy of the test articles when applied twice daily for 14 days in subjects with Grade I or II hemorrhoids. These products reflect common drug combinations of lidocaine hydrochloride or hydrocortisone acetate found in many prescription hemorrhoid products.
Detailed description
This is a multi-center, randomized, double-blind, parallel group comparison study in approximately 196 enrolled subjects (~28 subjects/test article) at approximately eight (8) sites. A minimum of 147 patients will be enrolled. Up to an additional 56 subjects (up to 196 subjects) may be enrolled based on enrollment rates and availability of patients. Enrollment status reports will be periodically generated, and based on enrollment experience, additional randomization blocks will be assigned to sites with the potential to enroll additional subjects over a reasonable period of time.
Male and female subjects, ages 18 years and older, with a clinical diagnosis of symptomatic Grade I or Grade II hemorrhoids will be randomized to treatment with one of seven (7) test articles (1:1 for all groups):
- Vehicle Cream
- 3% Hydrocortisone Acetate Cream
- 0.5% Hydrocortisone Acetate Cream
- 5% Lidocaine Hydrochloride Cream
- 1% Lidocaine Hydrochloride Cream
- 3% Hydrocortisone Acetate Cream and 5% Lidocaine Hydrochloride Cream
- 0.5% Hydrocortisone Acetate Cream and 1% Lidocaine Hydrochloride Cream
The test articles will be applied twice daily for two (2) weeks (14 days) to the peri-rectal area as well as the distal aspect of the anal canal using the product applicator tip.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Vehicle cream | Placebo comparator | Drug: Placebo controlPlacebo control base cream |
| 3% hydrocortisone | Experimental | Drug: Hydrocortisone acetate3% Hydrocortisone acetate cream |
| 0.5% hydrocortisone | Experimental | Drug: Hydrocortisone acetate0.5% Hydrocortisone acetate cream |
| 5% lidocaine | Experimental | Drug: Lidocaine hydrochloride5% Lidocaine hydrochloride cream |
| 1% lidocaine | Experimental | Drug: Lidocaine hydrochloride1% Lidocaine hydrochloride cream |
| 3% Hydro 5% Lido | Experimental | Drug: Hydrocortisone acetate and lidocaine hydrochlorideHydrocortisone acetate and lidocaine hydrochloride at 3% and 5% cream |
| 0.5% Hydro 1% Lido | Experimental | Drug: Hydrocortisone acetate and lidocaine hydrochlorideHydrocortisone acetate and lidocaine hydrochloride at 0.5% and 1% cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is male or non-pregnant female 18 years of age or older, in generally good health. Females must be post-menopausal, surgically sterile or have a negative urine pregnancy test (UPT) at the Baseline Visit and agree to use birth control during the study.
- Subject has provided written and verbal informed consent.
- Subject presents to the clinic with clinically confirmed symptomatic Grade I or II hemorrhoids (GSDS ≥ 2).
- Subject is willing and able to comply with study instructions and return to the clinic for required visits.
Key exclusion criteria (15 listed)
- Subject is female and lactating or planning to become pregnant during the study.
- Subject has anorectal condition(s) such as malignant tumors of the anus or rectum, fistula-in-ano or chronic sepsis, fissure-in-ano, incontinence, condylomata and Grade III and IV hemorrhoids.
- Subject has a history of previous proctological surgery or has active inflammatory bowel disease.
- Subject may use stool softeners, but shall be on a stable regimen for at least 28 days prior to enrolling in the study.
- Subject used the following systemic, oral or topical therapies for the periods specified prior to entry into the study:
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 |
|---|---|---|
| Hydrocortisone acetate and lidocaine hydrochlorideHydrocortisone and lidocaine in combination | Drug | 0.5% Hydro 1% Lido, 3% Hydro 5% Lido |
| Placebo controlVehicle cream alone | Drug | Vehicle cream |
| Hydrocortisone acetatehydrocortisone alone | Drug | 0.5% hydrocortisone, 3% hydrocortisone |
| Lidocaine hydrochloridelidocaine alone | Drug | 1% lidocaine, 5% lidocaine |
Primary outcome
Global score of disease severity
Time frame: up to 14 days
A measure overall discomfort on a scale of 0 to 5
6 secondary outcomes
Individual signs and symptoms
Time frame: up to 14 days
Onset of relief of symptoms
Time frame: 4 hours following product administration
Recurrence of symptoms
Time frame: 4 hours following product administration
Severity and frequency of adverse events
Time frame: 14 days
Laboratory assessment
Time frame: 14 days
Electrocardiography
Time frame: 14 days
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 24 Feb 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.
Alan S. Lader, Ph.D. study director
Citius Pharmaceuticals, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydrocortisone acetate and lidocaine hydrochloride, Hydrocortisone acetate and Lidocaine hydrochloride in people with Hemorrhoids, run by Citius Pharmaceuticals, Inc..
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 4 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 24 Feb 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Global score of disease severity (time frame: up to 14 days). 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 24 Feb 2016.