Fecal IncontinencePhase 1NCT01406925
Safety and Tolerability of a Single Intra-anal Dose of NRL001 in Healthy Volunteers
A Phase 1 study testing NRL001 cream in people with Fecal Incontinence, run by Norgine at 1 site in Bulgaria.
Trial summary
This study is conducted to explore the safety and tolerability and plasma pharmacokinetics of NRL001 after single intra-anal dose of 1mL cream at increasing concentrations. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- NRL001 cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBulgaria
- Study dates
- Apr 2007to Jun 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- IN.1) sex: male and female (non-child-bearing potential or using medically adequate contraception
- IN.2) race: Caucasian
- IN.3) BW: 50 - 100 kg
- IN.4) BMI: 20 - 28 kg.m-2
- IN.5) age: 21 - 50 years
- IN.6) type: healthy on the basis of specified criteria evaluated at the screening visit
- IN.7) willing and able to provide informed consent
Who cannot join
- General
- EX.1) Previous participation in the trial
- EX.2) Participant in any other trial during the last 90 days
- EX.3) Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
- EX.4) History of any clinically relevant allergy (including hypersensitivity to the trial medications)
- EX.5) Presence of acute or chronic infection
Show all 22Show fewer
- EX.6) Presence or history of any relevant co-morbidity
- EX.7) Resting systolic blood pressure > 140 or < 90 mmHg, diastolic blood pressure > 95 or < 50 mmHg
- EX.8) Clinically relevant ECG-abnormalities, prolonged QTc with > 450 msec in males and > 460 msec in females in particular
- EX.9) Presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes
- EX.10) Positive serology for HBsAg, anti HBc and anti HCV
- EX.11) Positive HIV test
- EX.12) Positive alcohol or urine drug test on recruitment (and upon admission)
- EX.13) History of alcohol and/or drug abuse and/or daily use of > 30 gr alcohol
- EX.14) Smoking more than 15 cigarettes/day or equivalent of other tobacco products
- EX.15) Use of prohibited medication
- EX.16) Suspicion or evidence that the subject is not trustworthy and reliable
- EX.17) Suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard
- General - all females
- EX.18) Positive pregnancy test
- EX.19) Lactating
- EX.20) Not using appropriate contraception in pre-menopausal women (note: under the conditions of the present study, women using hormonal contraceptives will be informed that this method is not sufficient during the study and that further i.e. mechanical methods [condom, diaphragm with spermicidal gel] should be used in addition).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Placebo-controlled, Double-blind, Cross-over Study in Healthy Men and Women to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intra-anal Doses of NRL001 for Three Doses Using a Cream Formulation Relative to a Matched Placebo Formulation for Reference
This study is conducted to explore the safety and tolerability and plasma pharmacokinetics of NRL001 after single intra-anal dose of 1mL cream at increasing concentrations.
- Conditions
- Fecal Incontinence
- Being tested
- Placebo control, NRL001 cream
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo controlDrug
Placebo cream
NRL001 creamDrug
Cream for single-dose intra-anal application
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Placebo control Receives: Drug: Placebo control |
| Low dose NRL001 | Experimental | 0.5% NRL001 cream Receives: Drug: NRL001 cream |
| Intermediate dose NRL001 | Experimental | 0.75% NRL001 cream Receives: Drug: NRL001 cream |
| High dose NRL001 | Experimental | 1.0% NRL001 cream Receives: Drug: NRL001 cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of NRL001
Measured: 30 mins, 1, 2, 3, 4, 5, 6, 8 and 12 hours after dosing
Secondary outcomes (2)
AUC of NRL001
Measured: 30 mins, 1, 2, 3, 4, 5, 6, 8 and 12 hours after dosing
Tolerability of NRL001
Spontaneously reported adverse events will be recorded
Measured: Up to 12 hours post-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startApr 2007
- Primary completionMay 2007
- Study completionJun 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hans Gruss, MD PhD, Study director, Norgine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406925
- Sponsor's protocol ID
- NRL001-02/2006(SD)
- Status last verified
- Jul 2011
- First submitted
- 29 Jul 2011
- Last updated
- 1 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-controlled, Double-blind, Cross-over Study in Healthy Men and Women to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intra-anal Doses of NRL001 for Three Doses Using a Cream Formulation Relative to a Matched Placebo Formulation for Reference
- ClinicalTrials.gov ID
- NCT01406925
- Acronym / sponsor ID
- NRL001-02/2006(SD)
- Conditions
- Fecal Incontinence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- May 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 1 Aug 2011 (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 study is conducted to explore the safety and tolerability and plasma pharmacokinetics of NRL001 after single intra-anal dose of 1mL cream at increasing concentrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Placebo controlPlacebo control |
| Low dose NRL001 | Experimental | Drug: NRL001 cream0.5% NRL001 cream |
| Intermediate dose NRL001 | Experimental | Drug: NRL001 cream0.75% NRL001 cream |
| High dose NRL001 | Experimental | Drug: NRL001 cream1.0% NRL001 cream |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- IN.1) sex: male and female (non-child-bearing potential or using medically adequate contraception
- IN.2) race: Caucasian
- IN.3) BW: 50 - 100 kg
- IN.4) BMI: 20 - 28 kg.m-2
- IN.5) age: 21 - 50 years
Key exclusion criteria (22 listed)
- General
- EX.1) Previous participation in the trial
- EX.2) Participant in any other trial during the last 90 days
- EX.3) Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
- EX.4) History of any clinically relevant allergy (including hypersensitivity to the trial medications)
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 |
|---|---|---|
| Placebo controlPlacebo cream | Drug | Control |
| NRL001 creamCream for single-dose intra-anal application | Drug | High dose NRL001, Intermediate dose NRL001, Low dose NRL001 |
Primary outcome
Cmax of NRL001
Time frame: 30 mins, 1, 2, 3, 4, 5, 6, 8 and 12 hours after dosing
2 secondary outcomes
AUC of NRL001
Time frame: 30 mins, 1, 2, 3, 4, 5, 6, 8 and 12 hours after dosing
Tolerability of NRL001
Time frame: Up to 12 hours post-dosing
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 1 Aug 2011.
Related trials for Fecal Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
Recruiting
At-Home Genital Nerve Stimulation for SCI Bowel
Spinal Cord Injury
Recruiting
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
Obstetric Anal Sphincter Injury
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
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 Gruss, MD PhD study director
Norgine
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 cream in people with Fecal Incontinence, run by Norgine at 1 site in Bulgaria.
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 7 inclusion and 22 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 1 Aug 2011. 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 Bulgaria. 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?
Cmax of NRL001 (time frame: 30 mins, 1, 2, 3, 4, 5, 6, 8 and 12 hours after dosing). 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 1 Aug 2011.