Fecal IncontinencePhase 1NCT00893607
Effect of Single Doses of 10 mg NRL001 Applied as a Suppository to the Anal Canal or Rectum
A Phase 1 study testing NRL001 in people with Fecal Incontinence, run by Norgine at 1 site in United Kingdom.
Trial summary
Study to assess the effects of 10mg NRL001 on mean anal resting pressure (MARP) when administered as a slow release suppository applied to the anal canal or rectum. In addition, the pharmacokinetics of NRL001 in plasma, adverse events, and any changes in heart rate or blood pressure were to be assessed. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- NRL001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2007to Dec 2007
- 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 cardiovascular disease
- 18 to 75 years of age
- Males and females (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 a vasodilatory activity
- Use of monoamine oxidase inhibitors (MAOI) presently or within the last two weeks before study participation
- Use of any medication in the last 30 days applied to the anus and/or via the rectum (exception: participation in NRL001-01/2006 (SUPP) for previous dosing into the anal canal)
- Application of any unlicensed medication within the previous 3 months (exception: participation in NRL001-01/2006 (SUPP))
- Regular intake of more than 21 units of alcohol per week
- History or any evidence of cardiovascular disease including ischaemic heart disease and hypertension (defined on examination: systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 90mmHg; based on at least two separate readings), peripheral vascular disease or Raynaud's syndrome
Show all 12Show fewer
- Presence of diabetes mellitus
- History or symptoms of thyroid diseases, including hypo- or hyperthyroidism
- 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
Division of GI Surgery, 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 Response to a Single Dose of 10mg Methoxamine (NRL001) Applied Locally Using a Suppository to the Anal Canal or Rectum
Study to assess the effects of 10mg NRL001 on mean anal resting pressure (MARP) when administered as a slow release suppository applied to the anal canal or rectum. In addition, the pharmacokinetics of NRL001 in plasma, adverse events, and any changes in heart rate or blood pressure were to be assessed.
- Conditions
- Fecal Incontinence
- Being tested
- NRL001
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRL001Drug
Also called Methoxamine Hydochloride
10mg NRL001 was administered as a slow release suppository
| Study group | Role | What they receive |
|---|---|---|
| Intra-anal | Experimental | The first 12 subjects were administered 10mg NRL001 as a slow release suppository into the anal canal. Receives: Drug: NRL001 |
| Rectal | Experimental | The second 12 subjects were administered 10mg NRL001 as a slow release rectal suppository. Receives: Drug: NRL001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean anal resting pressure (MARP)
Measured: Up to 6 hours post-dose
Secondary outcomes (2)
Pharmacokinetics of NRL001 in plasma
Measured: Up to 6 hours post-dose
Monitoring of blood pressure and heart rate
Measured: Up to 6 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startApr 2007
- Primary completionAug 2007
- Study completionDec 2007
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John H Scholefield, Principal investigator, University Hospital - Queens Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893607
- Sponsor's protocol ID
- NRL001-01/2006 (SUPP)
- Status last verified
- May 2009
- First submitted
- 5 May 2009
- Last updated
- 6 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2009. 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 Response to a Single Dose of 10mg Methoxamine (NRL001) Applied Locally Using a Suppository to the Anal Canal or Rectum
- ClinicalTrials.gov ID
- NCT00893607
- Acronym / sponsor ID
- NRL001-01/2006 (SUPP)
- Conditions
- Fecal Incontinence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 May 2009 (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.
Study to assess the effects of 10mg NRL001 on mean anal resting pressure (MARP) when administered as a slow release suppository applied to the anal canal or rectum. In addition, the pharmacokinetics of NRL001 in plasma, adverse events, and any changes in heart rate or blood pressure were to be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-anal | Experimental | Drug: NRL001The first 12 subjects were administered 10mg NRL001 as a slow release suppository into the anal canal. |
| Rectal | Experimental | Drug: NRL001The second 12 subjects were administered 10mg NRL001 as a slow release rectal suppository. |
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 cardiovascular disease
- 18 to 75 years of age
- Males and females (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 (12 listed)
- Use of medication in the last 30 days with a vasodilatory activity
- Use of monoamine oxidase inhibitors (MAOI) presently or within the last two weeks before study participation
- Use of any medication in the last 30 days applied to the anus and/or via the rectum (exception: participation in NRL001-01/2006 (SUPP) for previous dosing into the anal canal)
- Application of any unlicensed medication within the previous 3 months (exception: participation in NRL001-01/2006 (SUPP))
- Regular intake of more than 21 units of alcohol per week
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 |
|---|---|---|
| NRL001Also: Methoxamine Hydochloride10mg NRL001 was administered as a slow release suppository | Drug | Intra-anal, Rectal |
Primary outcome
Change in mean anal resting pressure (MARP)
Time frame: Up to 6 hours post-dose
2 secondary outcomes
Pharmacokinetics of NRL001 in plasma
Time frame: Up to 6 hours post-dose
Monitoring of blood pressure and heart rate
Time frame: Up to 6 hours post-dose
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 6 May 2009.
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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.
John H Scholefield 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 NRL001 in people with Fecal 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 12 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 6 May 2009. 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?
Change in mean anal resting pressure (MARP) (time frame: Up to 6 hours post-dose). 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 6 May 2009.