Cystic FibrosisPhase 2NCT00103714
Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease
A Phase 2 study testing denufosol tetrasodium (INS37217) in people with Cystic Fibrosis, run by Merck Sharp & Dohme LLC.
Trial summary
The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease. Read more about this study
- Who is it for?
- Ages 8 to 50 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- denufosol tetrasodium (INS37217)
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Aug 2005
- Phase
- Phase 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 8 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have confirmed diagnosis of CF
- Have an FEV1 greater than or equal to 60% or less than or equal to 90% of predicted normal
- Have oxygen saturation greater than or equal to 90% on room air
- Be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation
- Be able to reproducibly perform spirometry maneuvers
Who cannot join
- Have changed their physiotherapy technique or schedule within 7 days prior to screening
- Have clinically significant comorbidities
- Using prior and concurrent medications according to the protocol
About this study
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Cystic Fibrosis Lung Disease
The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.
- Conditions
- Cystic Fibrosis
- Being tested
- denufosol tetrasodium (INS37217)
- Keywords
- lung disease
- Medical subject headings
- Cystic Fibrosis, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
denufosol tetrasodium (INS37217)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory function
Secondary outcomes (4)
adverse events
change in standard safety parameters
respiratory symptoms via questionnaire
pulmonary exacerbation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2005 (estimated)
- Study startJan 2005
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy Schaberg, BSN, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103714
- Sponsor's protocol ID
- 08-104
- Status last verified
- Oct 2015
- First submitted
- 14 Feb 2005
- Last updated
- 20 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Cystic Fibrosis Lung Disease
- ClinicalTrials.gov ID
- NCT00103714
- Acronym / sponsor ID
- 08-104
- Conditions
- Cystic Fibrosis
- Keywords
- lung disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 15 Feb 2005 (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.
The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 8 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Have confirmed diagnosis of CF
- Have an FEV1 greater than or equal to 60% or less than or equal to 90% of predicted normal
- Have oxygen saturation greater than or equal to 90% on room air
- Be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation
- Be able to reproducibly perform spirometry maneuvers
Key exclusion criteria (3 listed)
- Have changed their physiotherapy technique or schedule within 7 days prior to screening
- Have clinically significant comorbidities
- Using prior and concurrent medications according to the protocol
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 |
|---|---|---|
| denufosol tetrasodium (INS37217) | Drug | – |
Primary outcome
respiratory function
4 secondary outcomes
adverse events
change in standard safety parameters
respiratory symptoms via questionnaire
pulmonary exacerbation
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 20 Oct 2015.
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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.
Amy Schaberg, BSN study director
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing denufosol tetrasodium (INS37217) in people with Cystic Fibrosis, run by Merck Sharp & Dohme LLC.
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 5 inclusion and 3 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 20 Oct 2015. 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 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?
respiratory function. 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 20 Oct 2015.