Anal Resting PressurePhase 1/2NCT00816205
An Open Label Study to Examine the Effect of Coated Nifedipine Suppositories on Anal Pressure in Healthy Subjects
A Phase 1/2 study testing Coated Nifedipine Suppositories in people with Anal Resting Pressure, run by RDD Pharma Ltd at 1 site in Israel.
Trial summary
This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study. Within one week after the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one day treatment period. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anal Resting Pressure
- What is being tested?
- Coated Nifedipine Suppositories
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento Apr 2009
- Phase
- Phase 1/2
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects meeting the following criteria will be eligible to participate in the trial:
- Signed written informed consent;
- Male or female subjects 18 to 55 years of age;
Who cannot join
- Subjects are excluded from participation in the study if any of the following criteria apply:
- Has a clinically significant history or presence of any of the following conditions:
- Known allergy to Nifedipine, polyethylene-glycol, Propylene-glycol or silicone.
- Active or past history of disease that requires medication or clinical follow up.
- Malignant disease within 5 years of screening;
- History of ano rectal disease.
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- History of gastrointestinal disease.
- History of gastrointestinal bleeding.
- History of rectal surgery.
- History of gastrointestinal surgery.
- History of HIV.
- In need of chronic use of medication, with the exception of birth control medications.
- Currently uses medication for acute illness.
- Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula., infection or space occupying lesion.
- Has received any investigational drug within 90 days of screening;
- Receipt of any investigational treatment (drug or device) within 90 days prior to screening;
Trial locations and contacts
1 site in 1 country.
About this study
This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study.
Within one week after the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one day treatment period. During this period, 4 anal manometric studies will take place. Study medication (Coated Nifedipine suppositories at various doses) will be administered at pre-determined intervals. During the study, blood samples will be obtained for plasma Nifedipine analysis.
Read the detailed description
After detrminig baseline resting anal pressure with a manometric test, coated Suppositories will be administered intra rectally. Subjects will take rectally a total of 3 Coated Suppositories per study. 90 minutes after each coated suppository insertion this suppository will be removed and a amnometric study will be performed:
The first dose will contain 4 mg of Nifedipine and the manomentric measurement performed afterwards will be used to determine baseline anal pressures.
The second dose will contain 12 mg of Nifedipine. The third dose will contain 24 mg of Nifedipine. The primary efficacy parameter is change in Resting Anal Pressure from baseline.
The secondary efficacy parameters include the following:
- The ratio of change in anal pressure to plasma Nifedipine level.
- The ratio of change in anal pressure to change in blood pressure.
- The ratio of change in anal pressure to change in heart rate.
- Conditions
- Anal Resting Pressure
- Being tested
- Coated Nifedipine Suppositories
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coated Nifedipine SuppositoriesDrug
Subjects will take rectally a total of 3 Coated Suppositories per study. 90 minutes after each coated suppository insertion this suppository will be removed and a amnometric study will be performed:
The first dose will contain 4 mg of Nifedipine and the manomentric measurement performed afterwards will be used to determine baseline anal pressures.
The second dose will contain 12 mg of Nifedipine. The third dose will contain 24 mg of Nifedipine.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | This is an open label, dose-finding study. After detrminig baseline resting anal pressure with a manometric test, coated Suppositories will be administered intra rectally. Subjects will take rectally a total of 3 Coated Suppositories per study. Receives: Drug: Coated Nifedipine Suppositories |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy parameter is change in Resting Anal Pressure from baseline.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2009 (estimated)
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal Resting PressureStudies 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 1/2
- Allocation
- Not applicable
- Intervention model
- Single group
Sponsor and investigators
- Lead sponsor
- RDD Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816205
- Sponsor's protocol ID
- RDD102
- Status last verified
- Apr 2009
- First submitted
- 31 Dec 2008
- Last updated
- 7 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Examine the Effect of Coated Nifedipine Suppositories on Anal Pressure in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00816205
- Acronym / sponsor ID
- RDD102
- Conditions
- Anal Resting Pressure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- RDD Pharma LtdIndustry (pharma, biotech, devices)
- Study completion
- Apr 2009 (actual)
- First posted
- 1 Jan 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.
This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study.
Within one week after the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one day treatment period. During this period, 4 anal manometric studies will take place. Study medication (Coated Nifedipine suppositories at various doses) will be administered at pre-determined intervals. During the study, blood samples will be obtained for plasma Nifedipine analysis.
Detailed description
After detrminig baseline resting anal pressure with a manometric test, coated Suppositories will be administered intra rectally. Subjects will take rectally a total of 3 Coated Suppositories per study. 90 minutes after each coated suppository insertion this suppository will be removed and a amnometric study will be performed:
The first dose will contain 4 mg of Nifedipine and the manomentric measurement performed afterwards will be used to determine baseline anal pressures.
The second dose will contain 12 mg of Nifedipine. The third dose will contain 24 mg of Nifedipine. The primary efficacy parameter is change in Resting Anal Pressure from baseline.
The secondary efficacy parameters include the following:
- The ratio of change in anal pressure to plasma Nifedipine level.
- The ratio of change in anal pressure to change in blood pressure.
- The ratio of change in anal pressure to change in heart rate.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Coated Nifedipine SuppositoriesThis is an open label, dose-finding study. After detrminig baseline resting anal pressure with a manometric test, coated Suppositories will be administered intra rectally. Subjects will take rectally a total of 3 Coated Suppositories per study. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Signed written informed consent;
- Male or female subjects 18 to 55 years of age;
Key exclusion criteria (16 listed)
- Subjects are excluded from participation in the study if any of the following criteria apply:
- Known allergy to Nifedipine, polyethylene-glycol, Propylene-glycol or silicone.
- Active or past history of disease that requires medication or clinical follow up.
- Malignant disease within 5 years of screening;
- History of ano rectal disease.
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 |
|---|---|---|
| Coated Nifedipine SuppositoriesSubjects will take rectally a total of 3 Coated Suppositories per study. 90 minutes after each coated suppository insertion this suppository will be removed and a amnometric study will be performed: The first dose will contain 4 mg of Nifedipine and the manomentric measurement performed afterwards will be used to determine baseline anal pressures. The second dose will contain 12 mg of Nifedipine. The third dose will contain 24 mg of Nifedipine. | Drug | Single Arm |
Primary outcome
The primary efficacy parameter is change in Resting Anal Pressure from baseline.
Time frame: 1 day
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 7 Apr 2009.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Coated Nifedipine Suppositories in people with Anal Resting Pressure, run by RDD Pharma Ltd at 1 site in Israel.
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 3 inclusion and 16 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 7 Apr 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 Israel. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary efficacy parameter is change in Resting Anal Pressure from baseline. (time frame: 1 day). 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 7 Apr 2009.