Fecal IncontinencePhase 1NCT03529487
Intra-anal Oxymetazoline in Healthy Adult Volunteers
A Phase 1 study testing Oxymetazoline in people with Fecal Incontinence, run by RDD Pharma Ltd at 1 site in United States.
Trial summary
This is a Phase 1, open-label, repeat dose, ascending dose study assessing the PK, safety, tolerability, PD, and dose- or exposure-response of Topical Oxymetazoline for intra-anal application. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Oxymetazoline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2018to 1 Dec 2023
- Phase
- Phase 1
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
- Subject is an adult male or female between the ages of 18 and 60 years, inclusive.
- Female subjects of child-bearing potential must have a negative urine pregnancy test. Females of childbearing potential must practice a highly effective method of pregnancy prevention (defined as <1% pregnancies per 100 women per year) from one month before screening to one month after the follow-up visit, such as: surgical sterilization, hormonal implant, intrauterine device, or male condom + female diaphragm + vaginal spermicide. Female subject with any of the following circumstances is not required to use a highly effective method of pregnancy prevention: status post-hysterectomy; or, status post-tubal ligation; or, post-menopausal state (defined as >= 12 months of spontaneous amenorrhea) or < 12 months of spontaneous amenorrhea with a blood follicle stimulating hormone > 40 MIU/ml.
- Subject has a body mass index between 18 and 33 kg/m2 (weight/[height]2).
- Subject has normal (or abnormal and clinically insignificant) laboratory values at Screening.
- Subject is healthy based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring and have no more than 3 spontaneous bowel movements (SBM) a day or no less than 3 SBMs a week.
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- Based on single or averaged QTc values of triplicate ECGs over a brief recording period, QTc < 450 msec
- Subject has the ability to understand the requirements of the study and a willingness to comply with all study procedures, including retaining a rectal gel for at least 60 min and undergoing repeat rectal manometries lasting 10-15 min.
- Subject has not consumed and agrees to abstain from taking any prescription or non-prescription medications, including herbal and dietary supplements (such as St. John's wort) within 14 days prior to the first dose of study medication (except as authorized by the Investigator and Medical Monitor).
- Subject has not consumed alcohol-containing beverages for 3 days prior to the first scheduled dose and agrees not to consume alcohol through the last study visit.
- Subject has not used tobacco- and nicotine-containing products for 2 months prior to the first scheduled dose and agrees not to use through the last study visit.
Who cannot join
- Subject has a hypersensitivity or allergy to oxymetazoline.
- Subject has active or history of cardiovascular or cerebrovascular disease including hypertension, unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities.
- Subject has systolic blood pressure >130 mm Hg and/or diastolic blood pressure >80 mm Hg and/or resting heart rate >90 bpm or resting heart rate <50 bpm.
- Subject has glaucoma (narrow-angle), Raynaud's disease/phenomenon, thromboangiitis obliterans, scleroderma, and/or Sjögren's syndrome.
- Subject has diabetes per medical history or has fasting plasma glucose level > 7 mmol/l (126 mg/dl) at screening or has Glycated hemoglobin (HbA1C) ≥ 48 mmol/mol (≥ 6.5 DCCT %) at screening.
- Subject has thyroid problems such as medical history of hypothyroidism, hyperthyroidism, sick euthyroid syndrome, thyroid cancer, thyroid surgery, Radioiodine treatment or enlarged thyroid upon physical examination, or thyroid nodule upon physical examination, or abnormal thyroid-stimulating hormone (TSH) at screening defined as level >4.0 mIU/mL or level <0.4 mIU/mL.
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- Subject with enlarged prostate as per medical history or per rectal examination in screening.
- Subject has a history of rectal surgery.
- Subject has upon physical examination a rectal deformation or signs of rectal disease such as fissure, hemorrhoids grade 3, rectal prolapse, fistula, infection or space occupying lesion.
- Subjects with a history of or present symptoms related to irritable bowel disease, inflammatory bowel disease, or chronic constipation.
- Subject reporting change in bowel habits in the last 14 days.
- Subject reporting episodes of rectal bleeding in the last 90 days.
- Subjects taking anticoagulants such as Coumarins, Heparins, and Factor Xa inhibitors.
- Subjects taking drugs known to affect rectal tone: nitrates, calcium channel blockers, alpha antagonists, and alpha agonists.
- Subjects taking beta-blockers, and/or cardiac glycosides.
- Subjects taking anti-hypertensives such as diuretics, beta blockers, alpha antagonists, sympatholytics, ACE inhibitors, angiotensin II antagonists, renin inhibitors, calcium antagonists or direct vasodilators.
- Subjects taking anti-diabetic medications such as insulin, Biguanides, α-Glucosidase Inhibitors, Dipeptidyl peptidase IV inhibitors, Insulin secretagogues, Sodium-glucose cotransporter 2 inhibitors, Thiazolidinediones, Amylin agonists, GLP-1 receptor-agonists.
- Subjects taking drugs affecting the thyroid such as levothyroxine, propylthiouracil, methimazole or amiodarone.
- Subject has a history illicit drug abuse in the past year or current evidence of such abuse in the opinion of the Investigator.
- Subject has positive findings on urine drug/alcohol/cotinine screen.
- Subject is positive for human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C on Screening assessments.
- Subject has an abnormal screening lab results judged by the investigator as clinically significant.
- Subject has thrombocytopenia defined as platelet level < 150,000 per microliter of blood.
- Subject is pregnant or lactating.
- Subject has an acute illness within 1 week of the first scheduled dose.
- Subject has donated plasma within 7 days of drug administration.
- Subject has donated 1 or more pints of blood (or equivalent blood loss) within 30 days prior to drug administration.
- Subject has participated in an investigational drug study where the last assessment of that study was within the 30 days prior to the first scheduled dose of this study.
- Subject is an immediate family member of personnel directly affiliated with the study, or is personally directly affiliated with the study at the investigative site, or is employed or related to the Sponsor, CRO or investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Clinical Research, LLC
West Bend, Wisconsin, 53095
About this study
Official title: A Phase I, Open-Label, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intra-anal Application of Topical Oxymetazoline Gel in Healthy Adult Volunteers
This is a Phase 1, open-label, repeat dose, ascending dose study assessing the PK, safety, tolerability, PD, and dose- or exposure-response of Topical Oxymetazoline for intra-anal application. A total of 32 healthy male and female subjects will be enrolled to receive either Topical Oxymetazoline 1 mg (Cohort A, n=16), 5 mg (Cohort B, n=8) and 10 mg (Cohort C, n=8) applied intra-anally daily (QD) for 11 consecutive days.
Read the detailed description
This is a Phase 1, open-label, repeat dose, ascending dose study assessing the PK, safety, tolerability, PD, and dose- or exposure-response of Topical Oxymetazoline for intra-anal application.
The primary objective of this study is to determine the plasma concentrations and PK parameters, as data allows, of oxymetazoline following single and repeated intra-anal application of oxymetazoline gel 1 mg, 5 mg or 10 mg in healthy male and female subjects.
The secondary objective of this study is to evaluate the safety and tolerability of repeated intra-anal application of oxymetazoline gel 1 mg, 5 mg or 10 mg in healthy male and female subjects.
A total of 32 healthy male and female subjects will be enrolled (16 subjects in the first cohort and 8 subjects in the remaining cohorts) and will be exposed to Topical Oxymetazoline 1 mg, 5 mg or 10 mg applied intra-anally QD for 11 consecutive days.
- Conditions
- Fecal Incontinence
- Being tested
- Oxymetazoline
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxymetazolineDrug
Oxymetazoline gel applied intra-analy
| Study group | Role | What they receive |
|---|---|---|
| Oxymetazoline applied intra analy | Experimental | Not described Receives: Drug: Oxymetazoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Oxymetazoline Maximum observed plasma concentration
Measured: 11 days
Tmax
Time to maximum concentration (Oxymetazoline), obtained directly from the observed concentration versus time data
Measured: 11 days
AUClast
Oxymetazoline Area under the plasma concentration-time curve from time 0 to time of last measureable plasma concentration
Measured: 11 days
t½
Oxymetazoline Terminal elimination half-life
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start20 Aug 2018
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RDD Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, Spaulding Clinical Research LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529487
- Sponsor's protocol ID
- RDD 121
- Status last verified
- Jul 2022
- First submitted
- 7 May 2018
- Last updated
- 2 Aug 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intra-anal Application of Topical Oxymetazoline Gel in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03529487
- Acronym / sponsor ID
- RDD 121
- Conditions
- Fecal Incontinence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RDD Pharma LtdIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense, Spaulding Clinical Research LLC
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 18 May 2018 (actual)
- 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.
This is a Phase 1, open-label, repeat dose, ascending dose study assessing the PK, safety, tolerability, PD, and dose- or exposure-response of Topical Oxymetazoline for intra-anal application. A total of 32 healthy male and female subjects will be enrolled to receive either Topical Oxymetazoline 1 mg (Cohort A, n=16), 5 mg (Cohort B, n=8) and 10 mg (Cohort C, n=8) applied intra-anally daily (QD) for 11 consecutive days.
Detailed description
This is a Phase 1, open-label, repeat dose, ascending dose study assessing the PK, safety, tolerability, PD, and dose- or exposure-response of Topical Oxymetazoline for intra-anal application.
The primary objective of this study is to determine the plasma concentrations and PK parameters, as data allows, of oxymetazoline following single and repeated intra-anal application of oxymetazoline gel 1 mg, 5 mg or 10 mg in healthy male and female subjects.
The secondary objective of this study is to evaluate the safety and tolerability of repeated intra-anal application of oxymetazoline gel 1 mg, 5 mg or 10 mg in healthy male and female subjects.
A total of 32 healthy male and female subjects will be enrolled (16 subjects in the first cohort and 8 subjects in the remaining cohorts) and will be exposed to Topical Oxymetazoline 1 mg, 5 mg or 10 mg applied intra-anally QD for 11 consecutive days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxymetazoline applied intra analy | Experimental | Drug: Oxymetazoline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
- Subject is an adult male or female between the ages of 18 and 60 years, inclusive.
- Female subjects of child-bearing potential must have a negative urine pregnancy test. Females of childbearing potential must practice a highly effective method of pregnancy prevention (defined as <1% pregnancies per 100 women per year) from one month before screening to one month after the follow-up visit, such as: surgical sterilization, hormonal implant, intrauterine device, or male condom + female diaphragm + vaginal spermicide. Female subject with any of the following circumstances is not required to use a highly effective method of pregnancy prevention: status post-hysterectomy; or, status post-tubal ligation; or, post-menopausal state (defined as >= 12 months of spontaneous amenorrhea) or < 12 months of spontaneous amenorrhea with a blood follicle stimulating hormone > 40 MIU/ml.
- Subject has a body mass index between 18 and 33 kg/m2 (weight/[height]2).
- Subject has normal (or abnormal and clinically insignificant) laboratory values at Screening.
Key exclusion criteria (29 listed)
- Subject has a hypersensitivity or allergy to oxymetazoline.
- Subject has active or history of cardiovascular or cerebrovascular disease including hypertension, unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities.
- Subject has systolic blood pressure >130 mm Hg and/or diastolic blood pressure >80 mm Hg and/or resting heart rate >90 bpm or resting heart rate <50 bpm.
- Subject has glaucoma (narrow-angle), Raynaud's disease/phenomenon, thromboangiitis obliterans, scleroderma, and/or Sjögren's syndrome.
- Subject has diabetes per medical history or has fasting plasma glucose level > 7 mmol/l (126 mg/dl) at screening or has Glycated hemoglobin (HbA1C) ≥ 48 mmol/mol (≥ 6.5 DCCT %) at screening.
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 |
|---|---|---|
| OxymetazolineOxymetazoline gel applied intra-analy | Drug | Oxymetazoline applied intra analy |
Primary outcome
Cmax
Time frame: 11 days
Oxymetazoline Maximum observed plasma concentration
Tmax
Time frame: 11 days
Time to maximum concentration (Oxymetazoline), obtained directly from the observed concentration versus time data
AUClast
Time frame: 11 days
Oxymetazoline Area under the plasma concentration-time curve from time 0 to time of last measureable plasma concentration
t½
Time frame: 11 days
Oxymetazoline Terminal elimination half-life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxymetazoline in people with Fecal Incontinence, run by RDD Pharma Ltd at 1 site 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 11 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Cmax (time frame: 11 days). The study lists 4 primary outcomes in all. 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 2 Aug 2022.