Internal HemorrhoidsPhase 2NCT01913158
Safety and Efficacy Study of Anucort HC TM 25mg Rectal Suppositories to Treat Symptomatic Internal Hemorrhoids
A Phase 2 study testing Anucort-HC, 25 Mg Rectal Suppository in people with Internal Hemorrhoids, run by G & W Laboratories Inc. at 3 sites in United States.
Trial summary
The primary objective of this study is to determine the safety and efficacy of G\&W Laboratories' Anucort HC TM (Hydrocortisone Acetate) 25mg Rectal Suppositories in subjects with internal hemorrhoidal symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Internal Hemorrhoids
- What is being tested?
- Anucort-HC, 25 Mg Rectal Suppository
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2013to Mar 2014
- 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
- Subjects with a diagnosis of symptomatic internal hemorrhoids will be selected to participate in the study.
- Eligible subjects will be males or non-pregnant, non-lactating, non-menstruating females; ≥ 18 years of age; with diagnosis of Grade I, II or III internal hemorrhoidal disease.
- For study entry the subject must have had anorectal bleeding during or after at least 2 of the 4 most recent attempted or successful bowel movements prior to Screening.
- Subject may also have one or more other symptoms: pain, itching or throbbing.
- At Visit 2/Day 1 (Randomization) subject must have recorded at least 2 instances of anorectal bleeding and no more than 1 incidence of no anorectal bleeding during attempted or successful bowel movements during the screening period between Visit 1/ Day -3 (Screening) and prior to Visit 2/Day 1 (Randomization).
Who cannot join
- History of permanent full-thickness rectal prolapse.
- Current anal fissures and/or infective anal pathology.
- Previous history of surgery for anorectal disease (within 1 year) or any other anorectal procedures
- Subjects who are mentally incapacitated such that informed consent cannot be obtained.
- Clinically significant co-morbid condition.
- Diagnosis of Inflammatory Bowel Disease (IBD).
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- Evidence or history of fecal incontinence.
- Clinically significant Laboratory values for hematology and chemistry .
- Subjects who have had oral, transdermal, or injectable steroid therapy within days from Visit 1/Screening.
- Presence of fissure or a fistula-in-ano, abscess, severe diverticular disease, polyps or colorectal adenoma or colorectal cancer, arteriovenous malformations, or any other pathological condition of the anus, colon or rectum other than symptomatic internal hemorrhoids which might be a potential cause of hematochezia.
- Clinically significant systemic disease.
- Pelvic radiation in the past or present.
- Use of any venotropic medications within 7 days from Visit 2/Day 1.
- Use of any anti-coagulant medications within 10 days from Visit 2/Day 1.
- Use of topical/anorectal corticosteroids for hemorrhoidal therapy within 7 days from Visit 2/Day 1.
- Use of topical/anorectal medicated hemorrhoidal therapy within 24 hours from Visit 2/Day 1.
- Unable to cease use of OTC or prescription medications for treatment of hemorrhoidal disease during study period.
- Immunocompromised subjects.
- Known hypersensitivity or allergies to Hydrocortisone Acetate or any component of the IP (in any dosage form).
- Use of any investigational drug or investigational device within 30 days prior to randomization.
- Previous participation in this study.
- Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subjects ability to comply with study requirements.
- Subjects unable to have a spontaneous bowl movement every day prior to randomization.
- Rectal varicies or portal hypertension.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clinical Research Associates
Huntsville, Alabama, 35801
IC Research
Sanford, Florida, 32771
Gastro Associates of Western Michigan
Wyoming, Michigan, 49519
About this study
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Evaluate Safety and Efficacy of Anucort HC TM (Hydrocortisone Acetate) 25mg Rectal Suppositories in the Treatment of Symptomatic Internal Hemorrhoids
The primary objective of this study is to determine the safety and efficacy of G\&W Laboratories' Anucort HC TM (Hydrocortisone Acetate) 25mg Rectal Suppositories in subjects with internal hemorrhoidal symptoms.
Read the detailed description
This is a randomized, vehicle-controlled, multicenter, double blind study of Anucort HC TM (Hydrocortisone Acetate) 25mg Rectal Suppositories in subjects with symptomatic internal hemorrhoids. Subjects will be randomly assigned in a 1:1 ratio to Test product or Vehicle, respectively.
Clinical evaluations will be performed at:
Visit 1/Day -3 (-1 day) to Day 1 Screening Visit 2/Day 1 Randomization (Start of Treatment) Visit 3/Day 8 (-1/+3 days) Interim Visit 4/Day 15 (-1/+3 days) End of Treatment / Early Termination Visit 5/ Day 28 (-1/+3 days)* 2 Weeks Post-Treatment/Follow-Up Phone Contact Safety will be assessed by monitoring adverse events (AEs) and clinically significant changes from Visit 1/Screening in laboratory values.
Number of Sites: Approximately 31 sites in the United States.
- Conditions
- Internal Hemorrhoids
- Being tested
- Anucort-HC, 25 Mg Rectal Suppository, Placebo suppository
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anucort-HC, 25 Mg Rectal SuppositoryDrug
Also called Hydrocortisone acetate suppositories
Hydrocortisone acetate suppositories
Placebo suppositoryDrug
Also called Hydrogenated palm kernel oil suppositories
Hydrogenated palm kernel oil suppositories
| Study group | Role | What they receive |
|---|---|---|
| Placebo suppository | Placebo comparator | Hydrogenated palm kernel oil suppositories Receives: Drug: Placebo suppository |
| Anucort-HC, 25 Mg Rectal Suppository | Active comparator | Hydrocortisone Acetate suppositories Receives: Drug: Anucort-HC, 25 Mg Rectal Suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding Cessation
The primary endpoint is bleeding cessation defined as cessation of anorectal bleeding associated with bowel movements or attempted bowel movements which does not recur after cessation for the remainder of the study period. The proportion of subjects with bleeding cessation using Anucort HCTM 25mg Rectal Suppositories will be compared statistically with the proportion of subjects using placebo.
Measured: Up to 18 days
Secondary outcomes (6)
Improvement in the Severity Score of Pain
Improvement in the Severity Score of Pain on the Visual Analogue Scale (VAS) from baseline to Visit 3/Day 8 and Visit 4 (End of Treatment)
Measured: Up To 18 days
Improvement in the Severity Score of Itching
Improvement in the Severity Score of Itching from baseline to Visit 3/Day 8 and Visit 4 (End of Treatment)
Measured: Up to 18 days
Improvement in the Severity Score of Throbbing
Improvement in the Severity Score of Throbbing to from baseline to Visit 3/Day 8 and Visit 4/Day 15 (End of Treatment)
Measured: Up to 18 days
Improvement in the Investigator Assessment
Improvement in the Investigator Assessment
Measured: Up to 18 days
Improvement in the Subject Global Assessment
Improvement in the Subject Global Assessment
Measured: Up to 18 days
Improvement in Severity of Bleeding
Improvement in the severity of Bleeding from baseline to Visit 3/Day 8 and Visit 4 (End of Treatment)
Measured: Up To 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- G & W Laboratories Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allan G Coates, DO, Principal investigator, Gastro Associates of Western Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913158
- Sponsor's protocol ID
- PRG-NY-13-002
- Status last verified
- Nov 2016
- First submitted
- 24 May 2013
- Last updated
- 3 Nov 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 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Evaluate Safety and Efficacy of Anucort HC TM (Hydrocortisone Acetate) 25mg Rectal Suppositories in the Treatment of Symptomatic Internal Hemorrhoids
- ClinicalTrials.gov ID
- NCT01913158
- Acronym / sponsor ID
- PRG-NY-13-002
- Conditions
- Internal Hemorrhoids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- G & W Laboratories Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 31 Jul 2013 (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 primary objective of this study is to determine the safety and efficacy of G\&W Laboratories' Anucort HC TM (Hydrocortisone Acetate) 25mg Rectal Suppositories in subjects with internal hemorrhoidal symptoms.
Detailed description
This is a randomized, vehicle-controlled, multicenter, double blind study of Anucort HC TM (Hydrocortisone Acetate) 25mg Rectal Suppositories in subjects with symptomatic internal hemorrhoids. Subjects will be randomly assigned in a 1:1 ratio to Test product or Vehicle, respectively.
Clinical evaluations will be performed at:
Visit 1/Day -3 (-1 day) to Day 1 Screening Visit 2/Day 1 Randomization (Start of Treatment) Visit 3/Day 8 (-1/+3 days) Interim Visit 4/Day 15 (-1/+3 days) End of Treatment / Early Termination Visit 5/ Day 28 (-1/+3 days)* 2 Weeks Post-Treatment/Follow-Up Phone Contact Safety will be assessed by monitoring adverse events (AEs) and clinically significant changes from Visit 1/Screening in laboratory values.
Number of Sites: Approximately 31 sites in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo suppository | Placebo comparator | Drug: Placebo suppositoryHydrogenated palm kernel oil suppositories |
| Anucort-HC, 25 Mg Rectal Suppository | Active comparator | Drug: Anucort-HC, 25 Mg Rectal SuppositoryHydrocortisone Acetate suppositories |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with a diagnosis of symptomatic internal hemorrhoids will be selected to participate in the study.
- Eligible subjects will be males or non-pregnant, non-lactating, non-menstruating females; ≥ 18 years of age; with diagnosis of Grade I, II or III internal hemorrhoidal disease.
- For study entry the subject must have had anorectal bleeding during or after at least 2 of the 4 most recent attempted or successful bowel movements prior to Screening.
- Subject may also have one or more other symptoms: pain, itching or throbbing.
- At Visit 2/Day 1 (Randomization) subject must have recorded at least 2 instances of anorectal bleeding and no more than 1 incidence of no anorectal bleeding during attempted or successful bowel movements during the screening period between Visit 1/ Day -3 (Screening) and prior to Visit 2/Day 1 (Randomization).
Key exclusion criteria (24 listed)
- History of permanent full-thickness rectal prolapse.
- Current anal fissures and/or infective anal pathology.
- Previous history of surgery for anorectal disease (within 1 year) or any other anorectal procedures
- Subjects who are mentally incapacitated such that informed consent cannot be obtained.
- Clinically significant co-morbid condition.
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 |
|---|---|---|
| Anucort-HC, 25 Mg Rectal SuppositoryAlso: Hydrocortisone acetate suppositoriesHydrocortisone acetate suppositories | Drug | Anucort-HC, 25 Mg Rectal Suppository |
| Placebo suppositoryAlso: Hydrogenated palm kernel oil suppositoriesHydrogenated palm kernel oil suppositories | Drug | Placebo suppository |
Primary outcome
Bleeding Cessation
Time frame: Up to 18 days
The primary endpoint is bleeding cessation defined as cessation of anorectal bleeding associated with bowel movements or attempted bowel movements which does not recur after cessation for the remainder of the study period. The proportion of subjects with bleeding cessation using Anucort HCTM 25mg Rectal Suppositories will be compared statistically with the proportion of subjects using placebo.
6 secondary outcomes
Improvement in the Severity Score of Pain
Time frame: Up To 18 days
Improvement in the Severity Score of Itching
Time frame: Up to 18 days
Improvement in the Severity Score of Throbbing
Time frame: Up to 18 days
Improvement in the Investigator Assessment
Time frame: Up to 18 days
Improvement in the Subject Global Assessment
Time frame: Up to 18 days
Improvement in Severity of Bleeding
Time frame: Up To 18 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 3 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.
Allan G Coates, DO principal investigator
Gastro Associates of Western Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anucort-HC, 25 Mg Rectal Suppository in people with Internal Hemorrhoids, run by G & W Laboratories Inc. at 3 sites in United States.
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 5 inclusion and 24 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 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Bleeding Cessation (time frame: Up to 18 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 3 Nov 2016.