Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying AsleepPhase 2NCT01196650
Comparison of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
A Phase 2 study testing IN 10 003 formulation A and IN 10 003 formulation B in people with Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep, run by Intec Pharma Ltd. at 3 sites in Israel.
Trial summary
This study aims to assess the efficacy of IN 10 003 in improving sleep parameters in patients with Insomnia exhibiting both difficulty in falling asleep and staying asleep. The study will compare 2 formulations of the IN 10 003 to placebo Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
- What is being tested?
- IN 10 003 formulation A and IN 10 003 formulation B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 3 sitesIsrael
- Study dates
- Sep 2010to not given
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects between the ages of 18 and 65 years of age
- Subjects that meet DSM IV diagnostic criteria for Insomnia
- Subjects that report a time in bed NLT 6.5 and NMT 9 hours
- Subjects that report on a one week sleep diary (on at least 3 of 7 nights) TST NMT 6.5 hours
- Subjects that report on a one week sleep diary (on at least 3 of 7 nights) Wake time after sleep >1.0 hour
- Subjects that report on a one week sleep diary (on at least 3 of 7 nights) NLT 30 minutes time to sleep onset
Show all 9Show fewer
- On two nights of PSG screening a mean WASO of ≥60 minutes with neither night less than 45 minutes
- On two nights of PSG screening a mean LPS of ≥20 minutes with neither night less than 15 minutes
- On two nights of PSG screening a TST of NMT 6.5 hours on each of the two nights
Who cannot join
- Subject has a circadian rhythm disorder including shift work or the need to travel NLT 3 time zones during the course of the study
- Use of any drug known to effect sleep or wake functions within 5 half lives of the drug or two weeks, whichever comes first.
- Subject with a history (past year) of alcohol or substance abuse
- Subject that needs to smoke during the sleep period time
- Subject that reports habitual napping (more than 3 times per week)
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Soroka University Medical Center
Beersheba
Rambam Medical Center
Haifa
Assuta Medical Center
Tel Aviv
About this study
Official title: A Double Blind, Polysomnographic, Three-Way Crossover Study to Compare the Efficacy of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
This study aims to assess the efficacy of IN 10 003 in improving sleep parameters in patients with Insomnia exhibiting both difficulty in falling asleep and staying asleep. The study will compare 2 formulations of the IN 10 003 to placebo
- Being tested
- IN 10 003 formulation A, IN 10 003 formulation B, Placebo capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN 10 003 formulation ADrug
IN 10 003 formulation BDrug
Placebo capsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | IN 10 003 formulation A Receives: Drug: IN 10 003 formulation A |
| 2 | Active comparator | IN 10 003 formulation B Receives: Drug: IN 10 003 formulation B |
| 3 | Placebo comparator | Placebo capsules Receives: Drug: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wake after sleep onset
To determine the effect of IN 10 003 on Wake time After Sleep Onset (WASO) as the change from baseline for the mean of night 1 and 2 relative to placebo
Secondary outcomes (1)
Objective and Subjective sleep parameters
Total Sleep Time, Latency to Persistent Sleep, Absence of residual effects,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study startSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying AsleepStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intec Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196650
- Sponsor's protocol ID
- IN 10 003
- Status last verified
- Sep 2010
- First submitted
- 5 Sep 2010
- Last updated
- 3 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Polysomnographic, Three-Way Crossover Study to Compare the Efficacy of IN 10 003 to Placebo in Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep
- ClinicalTrials.gov ID
- NCT01196650
- Acronym / sponsor ID
- IN 10 003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Intec Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- First posted
- 8 Sep 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 study aims to assess the efficacy of IN 10 003 in improving sleep parameters in patients with Insomnia exhibiting both difficulty in falling asleep and staying asleep. The study will compare 2 formulations of the IN 10 003 to placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: IN 10 003 formulation AIN 10 003 formulation A |
| 2 | Active comparator | Drug: IN 10 003 formulation BIN 10 003 formulation B |
| 3 | Placebo comparator | Drug: Placebo capsulesPlacebo capsules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects between the ages of 18 and 65 years of age
- Subjects that meet DSM IV diagnostic criteria for Insomnia
- Subjects that report a time in bed NLT 6.5 and NMT 9 hours
- Subjects that report on a one week sleep diary (on at least 3 of 7 nights) TST NMT 6.5 hours
- Subjects that report on a one week sleep diary (on at least 3 of 7 nights) Wake time after sleep >1.0 hour
Key exclusion criteria (5 listed)
- Subject has a circadian rhythm disorder including shift work or the need to travel NLT 3 time zones during the course of the study
- Use of any drug known to effect sleep or wake functions within 5 half lives of the drug or two weeks, whichever comes first.
- Subject with a history (past year) of alcohol or substance abuse
- Subject that needs to smoke during the sleep period time
- Subject that reports habitual napping (more than 3 times per week)
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 |
|---|---|---|
| IN 10 003 formulation A | Drug | 1 |
| IN 10 003 formulation B | Drug | 2 |
| Placebo capsules | Drug | 3 |
Primary outcome
Wake after sleep onset
To determine the effect of IN 10 003 on Wake time After Sleep Onset (WASO) as the change from baseline for the mean of night 1 and 2 relative to placebo
1 secondary outcome
Objective and Subjective sleep parameters
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 3 May 2011.
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IN 10 003 formulation A and IN 10 003 formulation B in people with Subjects With Insomnia Suffering From Difficulty in Falling Asleep and Staying Asleep, run by Intec Pharma Ltd. at 3 sites 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 9 inclusion and 5 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 3 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 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?
Wake after sleep onset. 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 3 May 2011.