Fecal IncontinencePhase 1NCT01175941
Effect of 7 Days of Dosing With a 10 mg Rectal Suppository of NRL001in Patients With Faecal Incontinence
A Phase 1 study testing NRL001 in people with Fecal Incontinence, run by Norgine at 1 site in United Kingdom.
Trial summary
This is a study to examine the effect of alpha adrenergic stimulation of the anal canal and rectum on parameters affecting the control of defecation in subjects with faecal incontinence. The study will investigate the effects of rectal suppositories containing 10 mg NRL001 given for seven days, once daily. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- NRL001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2010to Dec 2011
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient volunteers aged 40 to 85 years without clinically significant or uncontrolled cardiovascular, renal or hepatic disease (as determined by medical history, physical examination, laboratory test values, vital signs, and electrocardiograms [ECGs] at screening)
- Patients with mild/moderate passive faecal incontinence based on clinical symptomology and demonstrating the following criteria:
- ARP ≥20mmHg and ≤80mmHg
- Intact IAS as demonstrated by endoanal ultrasound
- Rectal capacity ≥150ml
- Cleveland Clinic Score ≥6 and ≤ 15
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- Body mass index (BMI) ≥ 16 and ≤ 32
- Able and willing to receive rectal treatments
- Able to voluntarily provide written informed consent to participate in the study
- Must understand the purposes and risks of the study and agree to follow the restrictions and schedule of procedures as defined in the protocol
- Female volunteers must be either postmenopausal (for at least one year and confirmed by serum FSH at screening), or surgically sterile, practising true sexual abstinence, or using Investigator-approved methods of contraception throughout the study until after post study physical examination and have a negative pregnancy test at screening
- Must be willing to consent to have data entered into The Over-Volunteering Prevention System
Who cannot join
- Patients with FI related to anatomical and/or traumatic sphincter defects
- Presence of any significant or uncontrolled cardiovascular, pulmonary, hepatic, renal, immunologic, neurological or psychiatric disease
- Concomitant ano-rectal conditions or diseases assessed as potentially interfering with the study medication by the Investigator (e.g. concomitant haemorrhoids, anal fissures). Conditions considered not interfering with the study medication are allowed
- Clinically relevant ECG-abnormalities with evident QTc prolongation and/or acute arrhythmia
- Current or history of drug or alcohol abuse
- Use of any disallowed concomitant medication, including over-the-counter items within 30 days prior to study drug administration until the end of the study
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- Use of any medication in the last 30 days applied via the rectum
- Use of any medication currently or within the last 30 days which the investigator believes may affect the study participation or results
- Unstable regimen of any statin, hypertensive or diuretic medication (patient volunteers must be on a stable regimen for at least 2 months)
- Participation in a clinical drug study during the 90 days preceding the initial dose in this study
- History of any allergy to nifedipine or any alpha-adrenoceptor antagonist or latex
- Consumption of alcoholic beverages within 24 hours prior to each dosing
- Patient volunteers who are considered not competent to consent to the trial or score less than 25 on the MMSE®
- Volunteers who, in the opinion of the Investigator, are unsuitable for participation in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queens Medical Centre
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Cross Over Study in Patient Volunteers With Faecal Incontinence to Evaluate the Effect on Rectal Compliance, Rectal Sensitivity, Recto-anal Inhibitory Reflex, Sphincter Pressures, Safety and Tolerability of a Daily Rectal Application of a 10 mg NRL001 Suppository for Seven Consecutive Days
This is a study to examine the effect of alpha adrenergic stimulation of the anal canal and rectum on parameters affecting the control of defecation in subjects with faecal incontinence. The study will investigate the effects of rectal suppositories containing 10 mg NRL001 given for seven days, once daily. Rectal compliance and median anal resting pressure will be considered the primary objective of the study. A pharmacokinetic evaluation plus safety and tolerability assessment including monitoring of electrocardiograms (ECGs), blood pressure and heart rate will also be evaluated as secondary objectives.
- Conditions
- Fecal Incontinence
- Being tested
- NRL001, Placebo control
- 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
10 mg NRL001 in a 2 g suppository, administered once daily for 7 days
Placebo controlDrug
Matched placebo - administered as a 2 g suppository, once daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| NRL001 | Experimental | 10 mg NRL001 in a 2 g suppository Receives: Drug: NRL001 |
| Placebo | Placebo comparator | Matched placebo control Receives: Drug: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean anal resting pressure and rectal compliance
Measured: 7 days
Secondary outcomes (3)
Rectal sensitivity
Measured: 7 days
Adverse events
Measured: 7 days
Plasma concentration over time
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2011
- Study completionDec 2011
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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan A Simpson, MD, Principal investigator, Nottingham University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175941
- Sponsor's protocol ID
- NRL001-01/2010 (MANO)
- Status last verified
- Nov 2012
- First submitted
- 4 Aug 2010
- Last updated
- 5 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Cross Over Study in Patient Volunteers With Faecal Incontinence to Evaluate the Effect on Rectal Compliance, Rectal Sensitivity, Recto-anal Inhibitory Reflex, Sphincter Pressures, Safety and Tolerability of a Daily Rectal Application of a 10 mg NRL001 Suppository for Seven Consecutive Days
- ClinicalTrials.gov ID
- NCT01175941
- Acronym / sponsor ID
- NRL001-01/2010 (MANO)
- Conditions
- Fecal Incontinence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Aug 2010 (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.
This is a study to examine the effect of alpha adrenergic stimulation of the anal canal and rectum on parameters affecting the control of defecation in subjects with faecal incontinence. The study will investigate the effects of rectal suppositories containing 10 mg NRL001 given for seven days, once daily. Rectal compliance and median anal resting pressure will be considered the primary objective of the study. A pharmacokinetic evaluation plus safety and tolerability assessment including monitoring of electrocardiograms (ECGs), blood pressure and heart rate will also be evaluated as secondary objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NRL001 | Experimental | Drug: NRL00110 mg NRL001 in a 2 g suppository |
| Placebo | Placebo comparator | Drug: Placebo controlMatched placebo control |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female patient volunteers aged 40 to 85 years without clinically significant or uncontrolled cardiovascular, renal or hepatic disease (as determined by medical history, physical examination, laboratory test values, vital signs, and electrocardiograms [ECGs] at screening)
- Patients with mild/moderate passive faecal incontinence based on clinical symptomology and demonstrating the following criteria:
- ARP ≥20mmHg and ≤80mmHg
- Intact IAS as demonstrated by endoanal ultrasound
- Rectal capacity ≥150ml
Key exclusion criteria (14 listed)
- Patients with FI related to anatomical and/or traumatic sphincter defects
- Presence of any significant or uncontrolled cardiovascular, pulmonary, hepatic, renal, immunologic, neurological or psychiatric disease
- Concomitant ano-rectal conditions or diseases assessed as potentially interfering with the study medication by the Investigator (e.g. concomitant haemorrhoids, anal fissures). Conditions considered not interfering with the study medication are allowed
- Clinically relevant ECG-abnormalities with evident QTc prolongation and/or acute arrhythmia
- Current or history of drug or alcohol abuse
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 |
|---|---|---|
| NRL00110 mg NRL001 in a 2 g suppository, administered once daily for 7 days | Drug | NRL001 |
| Placebo controlMatched placebo - administered as a 2 g suppository, once daily for 7 days | Drug | Placebo |
Primary outcome
Mean anal resting pressure and rectal compliance
Time frame: 7 days
3 secondary outcomes
Rectal sensitivity
Time frame: 7 days
Adverse events
Time frame: 7 days
Plasma concentration over time
Time frame: 7 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 5 Nov 2012.
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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.
Jonathan A Simpson, MD principal investigator
Nottingham University Hospital
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 12 inclusion and 14 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 5 Nov 2012. 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. 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 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 and rectal compliance (time frame: 7 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 5 Nov 2012.