Faecal IncontinencePhase 1NCT06593730
Safety and Tolerability of the Twice Daily Intra-anal Application of NRL001 Cream for 14 Days
A Phase 1 study testing NRL001 cream 0.5%w/w, NRL001 cream 0.75%w/w and NRL001 cream 1.0%w/w in people with Faecal Incontinence, run by Norgine.
Trial summary
The study is being conducted to evaluate the safety and tolerability after single and repeated twice daily intra-anal applications of 1mL NRL001 cream in stepwise increasing concentrations. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Faecal Incontinence
- What is being tested?
- NRL001 cream 0.5%w/w, NRL001 cream 0.75%w/w and NRL001 cream 1.0%w/w
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Sep 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females (only females of non-child-bearing potential or of child-bearing potential while taking medically appropriate contraception)
- Caucasian
- 35 to 60 years of age (included)
- BMI: between 22 and 26 kg.m-2
- BW: between 50 and 100 kg
- Willing and able to provide written informed consent
Who cannot join
- General - all subjects
- Previous participation in the trial
- Participation in any other trial during the last 90 days
- Donation of blood or plasma within the last 90 days before recruitment
- History of any clinically relevant allergy
- Presence of acute or chronic infection
Show all 25Show fewer
- Presence or history of any relevant medical condition or disease (as evaluated on the basis of medical history, physical examination, recumbent and standing blood pressure, treadmill ergometry, clinical laboratory tests [haematology, clinical chemistry, urinalysis, serology])
- Presence or history of migraine, frequent headaches, Raynaud phenomenon, urinary urge, signs and symptoms of prostatism
- Presence or history of regular/habitual diarrhoea or constipation; previous anal surgery or trauma, anal fissures, rectal disorders
- Resting systolic blood pressure > 145 or < 90 mmHg, diastolic blood pressure > 95 or < 50 mmHg
- Positive treadmill ergometry test
- Resting pulse (PR) or electrocardiographic heart rate (HR) < 55 bpm
- ECG: AV-block (AV-block grade I included), QT > 480 msec, QTc > 450 msec, sick-sinus syndrome
- Positive hepatitis (HBs-Ag or HBc-Ab, HCV-Ab) or HIV serology test
- History of alcohol or (social) drug abuse
- Positive alcohol or urine drug test
- Daily consumption of > 30 g alcohol
- Smoking more than 15 cigarettes/day or equivalent of other tobacco products
- Use of prohibited medication
- Suspicion or evidence that the subject is not reliable
- Suspicion or evidence that the subject is not able to make a free consent or to understand the information detailed in the Subject Information sheet.
- All females
- Positive pregnancy test
- Lactating
- Premenopausal women : not using contraception which is judged adequate and sufficient in the opinion of the clinical investigator
About this study
Official title: Double-blind, Placebo-controlled, Randomised, Parallel-group Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Twice Daily Intra-anal Application of NRL001-cream for 14 Days.
The study is being conducted to evaluate the safety and tolerability after single and repeated twice daily intra-anal applications of 1mL NRL001 cream in stepwise increasing concentrations.
Read the detailed description
Single-centre, randomised, placebo-controlled, double-blind, repeated dose study in healthy male and female volunteers, comprising up to six sequential dose groups receiving 1 mL doses of an investigational cream formulation containing 0.50, 0.75, 1.00, 1.50, 2.00 and 2.50% w/w NRL001. Doses were to be investigated in stepwise increasing fashion. Progression to a higher dose-step required completion of the previous dose-step without safety limiting findings. Each dose-step was to be investigated in 12 subjects; in each dose-group, subjects assigned to active treatment were to be studied in parallel with subjects assigned to placebo in double-blind fashion with random (9:3) treatment assignment. Each subject was to be studied for one study period with double-blind investigational treatment (1 mL of an investigational cream formulation containing NRL001 or matched placebo) twice daily from the morning of D01 to the afternoon of D14; this phase was to be preceded by a single-blind placebo control day (D-1) with administration of placebo in the morning and afternoon.
- Conditions
- Faecal Incontinence
- Being tested
- NRL001 cream 0.5%w/w, NRL001 cream 0.75%w/w, NRL001 cream 1.0%w/w, NRL001 cream 1.5%w/w, NRL001 cream 2.0%w/w
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRL001 cream 0.5%w/wDrug
Also called NRL001 (1R,2S-methoxamine) cream 0.5%w/w
NRL001 cream 0.75%w/wDrug
Also called NRL001 (1R,2S-methoxamine) cream 0.75%w/w
NRL001 cream 1.0%w/wDrug
Also called NRL001 (1R,2S-methoxamine) cream 1.0%w/w
NRL001 cream 1.5%w/wDrug
Also called NRL001 (1R,2S-methoxamine) cream 1.5%w/w
NRL001 cream 2.0%w/wDrug
Also called NRL001 (1R,2S-methoxamine) cream 2.0%w/w
NRL001 cream 2.5%w/wDrug
Also called NRL001 (1R,2S-methoxamine) cream 2.5%w/w
| Study group | Role | What they receive |
|---|---|---|
| NRL001 cream 0.5%w/w | Experimental | 0.5%w/w NRL001 (1R,2S-methoxamine) 1 mL, twice daily administration (morning and afternoon) for 14 days (study Days D1 to D14). Receives: Drug: NRL001 cream 0.5%w/w |
| NRL001 cream 0.75% w/w | Experimental | 0.75%w/w NRL001 (1R,2S-methoxamine) 1 mL, twice daily administration (morning and afternoon) for 14 days (study Days D1 to D14). Receives: Drug: NRL001 cream 0.75%w/w |
| NRL001 cream 1.0% w/w | Experimental | 1.0%w/w NRL001 (1R,2S-methoxamine) 1 mL, twice daily administration (morning and afternoon) for 14 days (study Days D1 to D14). Receives: Drug: NRL001 cream 1.0%w/w |
| NRL001 cream 1.5% w/w | Experimental | 1.5%w/w NRL001 (1R,2S-methoxamine) 1 mL, twice daily administration (morning and afternoon) for 14 days (study Days D1 to D14). Receives: Drug: NRL001 cream 1.5%w/w |
| NRL001 cream 2.0% w/w | Experimental | 2.0%w/w NRL001 (1R,2S-methoxamine) 1 mL, twice daily administration (morning and afternoon) for 14 days (study Days D1 to D14). Receives: Drug: NRL001 cream 2.0%w/w |
| NRL001 cream 2.5% w/w | Experimental | 2.5%w/w NRL001 (1R,2S-methoxamine) 1 mL, twice daily administration (morning and afternoon) for 14 days (study Days D1 to D14). Receives: Drug: NRL001 cream 2.5%w/w |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recumbent and standing blood pressure and pulse rate
BP and pulse taken lying and standing at screening, on control day and profiling days
Measured: 17 days
Ambulatory 24 hour BP monitoring
Ambulatory 24 hour BP monitoring on control day and profiling days
Measured: 17 days
12-lead digital resting ECG
12-lead digital resting ECG at screening, on control day and profiling days
Measured: 17 days
3-lead ambulatory 24 hour ECG monitoring
24 hour HOLTER monitoring at screening, on control day and profiling days
Measured: 17 days
Secondary outcomes (3)
Plasma concentrations of NRL001
Single and repeat dose pharmacokinetics of NRL001 in plasma
Measured: 17 days
Well being
Any untoward change in health and/or wellbeing
Measured: 17 days
Adverse events
Any unwanted sign or symptom
Measured: 17 days
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 startAug 2007
- Primary completionAug 2007
- Study completionSep 2007
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593730
- Sponsor's protocol ID
- NRL001-01/2007(RD)
- 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
- Double-blind, Placebo-controlled, Randomised, Parallel-group Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Twice Daily Intra-anal Application of NRL001-cream for 14 Days.
- ClinicalTrials.gov ID
- NCT06593730
- Acronym / sponsor ID
- NRL001-01/2007(RD)
- Conditions
- Faecal Incontinence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2007 (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.
The study is being conducted to evaluate the safety and tolerability after single and repeated twice daily intra-anal applications of 1mL NRL001 cream in stepwise increasing concentrations.
Detailed description
Single-centre, randomised, placebo-controlled, double-blind, repeated dose study in healthy male and female volunteers, comprising up to six sequential dose groups receiving 1 mL doses of an investigational cream formulation containing 0.50, 0.75, 1.00, 1.50, 2.00 and 2.50% w/w NRL001. Doses were to be investigated in stepwise increasing fashion. Progression to a higher dose-step required completion of the previous dose-step without safety limiting findings. Each dose-step was to be investigated in 12 subjects; in each dose-group, subjects assigned to active treatment were to be studied in parallel with subjects assigned to placebo in double-blind fashion with random (9:3) treatment assignment. Each subject was to be studied for one study period with double-blind investigational treatment (1 mL of an investigational cream formulation containing NRL001 or matched placebo) twice daily from the morning of D01 to the afternoon of D14; this phase was to be preceded by a single-blind placebo control day (D-1) with administration of placebo in the morning and afternoon.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| NRL001 cream 0.5%w/w | Experimental | Drug: NRL001 cream 0.5%w/w0.5%w/w NRL001 (1R,2S-methoxamine) 1 mL, twice daily administration (morning and afternoon) for 14 days (study Days D1 to D14). |
| NRL001 cream 0.75% w/w | Experimental | Drug: NRL001 cream 0.75%w/w0.75%w/w NRL001 (1R,2S-methoxamine) 1 mL, twice daily administration (morning and afternoon) for 14 days (study Days D1 to D14). |
| NRL001 cream 1.0% w/w | Experimental | Drug: NRL001 cream 1.0%w/w1.0%w/w NRL001 (1R,2S-methoxamine) 1 mL, twice daily administration (morning and afternoon) for 14 days (study Days D1 to D14). |
| NRL001 cream 1.5% w/w | Experimental | Drug: NRL001 cream 1.5%w/w1.5%w/w NRL001 (1R,2S-methoxamine) 1 mL, twice daily administration (morning and afternoon) for 14 days (study Days D1 to D14). |
| NRL001 cream 2.0% w/w | Experimental | Drug: NRL001 cream 2.0%w/w2.0%w/w NRL001 (1R,2S-methoxamine) 1 mL, twice daily administration (morning and afternoon) for 14 days (study Days D1 to D14). |
| NRL001 cream 2.5% w/w | Experimental | Drug: NRL001 cream 2.5%w/w2.5%w/w NRL001 (1R,2S-methoxamine) 1 mL, twice daily administration (morning and afternoon) for 14 days (study Days D1 to D14). |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males or females (only females of non-child-bearing potential or of child-bearing potential while taking medically appropriate contraception)
- Caucasian
- 35 to 60 years of age (included)
- BMI: between 22 and 26 kg.m-2
- BW: between 50 and 100 kg
Key exclusion criteria (25 listed)
- General - all subjects
- Previous participation in the trial
- Participation in any other trial during the last 90 days
- Donation of blood or plasma within the last 90 days before recruitment
- History of any clinically relevant allergy
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 |
|---|---|---|
| NRL001 cream 0.5%w/wAlso: NRL001 (1R,2S-methoxamine) cream 0.5%w/w | Drug | NRL001 cream 0.5%w/w |
| NRL001 cream 0.75%w/wAlso: NRL001 (1R,2S-methoxamine) cream 0.75%w/w | Drug | NRL001 cream 0.75% w/w |
| NRL001 cream 1.0%w/wAlso: NRL001 (1R,2S-methoxamine) cream 1.0%w/w | Drug | NRL001 cream 1.0% w/w |
| NRL001 cream 1.5%w/wAlso: NRL001 (1R,2S-methoxamine) cream 1.5%w/w | Drug | NRL001 cream 1.5% w/w |
| NRL001 cream 2.0%w/wAlso: NRL001 (1R,2S-methoxamine) cream 2.0%w/w | Drug | NRL001 cream 2.0% w/w |
| NRL001 cream 2.5%w/wAlso: NRL001 (1R,2S-methoxamine) cream 2.5%w/w | Drug | NRL001 cream 2.5% w/w |
Primary outcome
Recumbent and standing blood pressure and pulse rate
Time frame: 17 days
BP and pulse taken lying and standing at screening, on control day and profiling days
Ambulatory 24 hour BP monitoring
Time frame: 17 days
Ambulatory 24 hour BP monitoring on control day and profiling days
12-lead digital resting ECG
Time frame: 17 days
12-lead digital resting ECG at screening, on control day and profiling days
3-lead ambulatory 24 hour ECG monitoring
Time frame: 17 days
24 hour HOLTER monitoring at screening, on control day and profiling days
3 secondary outcomes
Plasma concentrations of NRL001
Time frame: 17 days
Well being
Time frame: 17 days
Adverse events
Time frame: 17 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 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NRL001 cream 0.5%w/w, NRL001 cream 0.75%w/w and NRL001 cream 1.0%w/w in people with Faecal Incontinence, run by Norgine.
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 6 inclusion and 25 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.
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?
Recumbent and standing blood pressure and pulse rate (time frame: 17 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 19 Sep 2024.