Faecal IncontinencePhase 1NCT06593743
The Safety and Dose Response to Single Anal Doses of NRL001
A Phase 1 study testing Perianal NRL001 Gel 3 strengths, Intraanal NRL001 Gel 2 strengths and Intrarectal NRL001 Gel in people with Faecal Incontinence, run by Norgine at 1 site in United Kingdom.
Trial summary
Single centre dose-finding and proof-of-concept study in healthy volunteers to assess the effects of single doses of NRL001 on the mean anal resting pressure (MARP). In addition, the pharmacokinetics of NRL001 and subject safety are also examined. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Faecal Incontinence
- What is being tested?
- Perianal NRL001 Gel 3 strengths, Intraanal NRL001 Gel 2 strengths and Intrarectal NRL001 Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2002to 12 Nov 2013
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No previous history of ano-rectal conditions/diseases.
- No history of heart disease.
- 18 to 75 years of age.
- Males and females but pre-menopausal females of child bearing potential must be using adequate contraceptive methods and have a negative pregnancy test before the start of the study.
Who cannot join
- Use of medication in the last 30 days with vasodilatory activity.
- Use of any medication in the last 30 days applied to the anus and/or via the rectum (exception: participation in Part A, Part B or Part C of NRL001-01/2002(HV)
- Regular intake of more than 21 units of alcohol per week.
- Pregnant females.
- Breast feeding mothers.
- Presence of concomitant gastrointestinal diseases or disorders, such as significant abdominal symptoms and haemorrhoids but also any significant organ (e.g. renal, hepatic or cardiac)dysfunction.
- Volunteers whom the investigator feels would not be compliant with the requirements of the trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital - Queens Medical Centre
Nottingham, NG7 2UH
About this study
Official title: Proof of Concept Study in Healthy Volunteers to Investigate the Safety and Dose Response to a Single Dose (0.3%,1% or 3%) of Methoxamine (NRL001)applied to the Anus
Single centre dose-finding and proof-of-concept study in healthy volunteers to assess the effects of single doses of NRL001 on the mean anal resting pressure (MARP). In addition, the pharmacokinetics of NRL001 and subject safety are also examined.
Read the detailed description
This is a single centre dose-finding and proof-of-concept study in healthy volunteers to assess the effects of single doses of NRL001 on the mean anal resting pressure (MARP). In addition, the pharmacokinetics of NRL001 and subject safety are also examined.
The study consists of four parts, which evaluate different NRL001 concentrations and sites of application. Treatments consist of a single local application of either 0.3%, 1% or 3% w/w NRL001 gel applied peri-anally, of either 1% or 3% w/w NRL001 gel applied intra-anally, or 1% w/w NRL001 administered rectally. In addition, a 10 mg NRL001-containing suppository applied to the rectum is assessed.
- Conditions
- Faecal Incontinence
- Being tested
- Perianal NRL001 Gel 3 strengths, Intraanal NRL001 Gel 2 strengths, Intrarectal NRL001 Gel, NRL001: 10mg suppository
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perianal NRL001 Gel 3 strengthsDrug
Also called methoxamine gel 0.3%, 1.0%, 3.0%
A single application of 0.3%, 1.0%, 3.0% NRL001 gel in stepwise dose ascending fashion.
Intraanal NRL001 Gel 2 strengthsDrug
Also called methoxamine gel 3.0%, 1.0%
A single application of 3.0% or 1.0% Gel
Intrarectal NRL001 GelDrug
Also called methoxamine gel 1.0%
A single application of 1.0% Gel
NRL001: 10mg suppositoryDrug
Also called methoxamine suppository
NRL001 10mg suppository applied to rectum.
| Study group | Role | What they receive |
|---|---|---|
| Perianal NRL001 Gel 3 strengths | Experimental | A single peri-anal application of NRL001 0.3%, 1%, 3% gel in stepwise dose ascending fashion. Receives: Drug: Perianal NRL001 Gel 3 strengths |
| Intraanal NRL001 Gel 2 strengths | Experimental | A single intra-anal application of 3% or 1% NRL001 gel. Receives: Drug: Intraanal NRL001 Gel 2 strengths |
| Intrarectal NRL001 Gel | Experimental | A single intra-rectal application of 1% NRL001 gel. Receives: Drug: Intrarectal NRL001 Gel |
| NRL001: 10mg suppository | Experimental | One 10mg NRL001 suppository applied to rectum. Receives: Drug: NRL001: 10mg suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean anal resting pressure
Mean anal resting pressure (MARP) was recorded using anal manometric catheter
Measured: Six hours at visit 2
Secondary outcomes (2)
Blood pressure (mmHg)
Blood pressure was measured before the application of the trial medication and then every 30 minutes for the first 2 hours after application, plus 2 hourly for the remaining follow-up period.
Measured: Six hours at visit 2
Pulse rate (beats per minute)
Pulse rate was measured before the application of the trial medication and then every 30 minutes for the first 2 hours after application, plus 2 hourly for the remaining follow-up period.
Measured: Six hours at visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startDec 2002
- Primary completionJul 2004
- Study completion12 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Faecal 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans-Jürgen Gruss, MD, Study director, NorgineJohn H Scholefield, MD, Principal investigator, University Hospital - Queens Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593743
- Sponsor's protocol ID
- NRL001-01/2002 (HV)
- Status last verified
- Sep 2024
- First submitted
- 9 Jun 2015
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Study in Healthy Volunteers to Investigate the Safety and Dose Response to a Single Dose (0.3%,1% or 3%) of Methoxamine (NRL001)applied to the Anus
- ClinicalTrials.gov ID
- NCT06593743
- Acronym / sponsor ID
- NRL001-01/2002 (HV)
- Conditions
- Faecal Incontinence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Jul 2004 (actual)
- Study completion
- 12 Nov 2013 (actual)
- First posted
- 19 Sep 2024 (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.
Single centre dose-finding and proof-of-concept study in healthy volunteers to assess the effects of single doses of NRL001 on the mean anal resting pressure (MARP). In addition, the pharmacokinetics of NRL001 and subject safety are also examined.
Detailed description
This is a single centre dose-finding and proof-of-concept study in healthy volunteers to assess the effects of single doses of NRL001 on the mean anal resting pressure (MARP). In addition, the pharmacokinetics of NRL001 and subject safety are also examined.
The study consists of four parts, which evaluate different NRL001 concentrations and sites of application. Treatments consist of a single local application of either 0.3%, 1% or 3% w/w NRL001 gel applied peri-anally, of either 1% or 3% w/w NRL001 gel applied intra-anally, or 1% w/w NRL001 administered rectally. In addition, a 10 mg NRL001-containing suppository applied to the rectum is assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Perianal NRL001 Gel 3 strengths | Experimental | Drug: Perianal NRL001 Gel 3 strengthsA single peri-anal application of NRL001 0.3%, 1%, 3% gel in stepwise dose ascending fashion. |
| Intraanal NRL001 Gel 2 strengths | Experimental | Drug: Intraanal NRL001 Gel 2 strengthsA single intra-anal application of 3% or 1% NRL001 gel. |
| Intrarectal NRL001 Gel | Experimental | Drug: Intrarectal NRL001 GelA single intra-rectal application of 1% NRL001 gel. |
| NRL001: 10mg suppository | Experimental | Drug: NRL001: 10mg suppositoryOne 10mg NRL001 suppository applied to rectum. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No previous history of ano-rectal conditions/diseases.
- No history of heart disease.
- 18 to 75 years of age.
- Males and females but pre-menopausal females of child bearing potential must be using adequate contraceptive methods and have a negative pregnancy test before the start of the study.
Key exclusion criteria (7 listed)
- Use of medication in the last 30 days with vasodilatory activity.
- Use of any medication in the last 30 days applied to the anus and/or via the rectum (exception: participation in Part A, Part B or Part C of NRL001-01/2002(HV)
- Regular intake of more than 21 units of alcohol per week.
- Pregnant females.
- Breast feeding mothers.
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 |
|---|---|---|
| Perianal NRL001 Gel 3 strengthsAlso: methoxamine gel 0.3%, 1.0%, 3.0%A single application of 0.3%, 1.0%, 3.0% NRL001 gel in stepwise dose ascending fashion. | Drug | Perianal NRL001 Gel 3 strengths |
| Intraanal NRL001 Gel 2 strengthsAlso: methoxamine gel 3.0%, 1.0%A single application of 3.0% or 1.0% Gel | Drug | Intraanal NRL001 Gel 2 strengths |
| Intrarectal NRL001 GelAlso: methoxamine gel 1.0%A single application of 1.0% Gel | Drug | Intrarectal NRL001 Gel |
| NRL001: 10mg suppositoryAlso: methoxamine suppositoryNRL001 10mg suppository applied to rectum. | Drug | NRL001: 10mg suppository |
Primary outcome
Mean anal resting pressure
Time frame: Six hours at visit 2
Mean anal resting pressure (MARP) was recorded using anal manometric catheter
2 secondary outcomes
Blood pressure (mmHg)
Time frame: Six hours at visit 2
Pulse rate (beats per minute)
Time frame: Six hours at visit 2
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 19 Sep 2024.
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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.
Hans-Jürgen Gruss, MD study director
Norgine
John H Scholefield, MD principal investigator
University Hospital - Queens Medical Centre
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 Perianal NRL001 Gel 3 strengths, Intraanal NRL001 Gel 2 strengths and Intrarectal NRL001 Gel in people with Faecal Incontinence, run by Norgine at 1 site in United Kingdom.
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 7 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 19 Sep 2024. 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 Kingdom. 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?
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 anal resting pressure (time frame: Six hours at visit 2). 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 19 Sep 2024.