InsomniaPhase 2NCT01277107
A Polysomnographic Study to Compare the Efficacy of Gastric Retentive Zaleplon Accordion Pill to Placebo in Subjects With Insomnia
A Phase 2 study testing Zaleplon AP formulation in people with Insomnia, run by Intec Pharma Ltd. at 6 sites in 2 countries.
Trial summary
This is a multi center, double blind placebo controlled, two-way crossover study in patients with Insomnia suffering from difficulty in falling asleep and staying asleep. This study intends to assess the efficacy of Zaleplon AP in improving sleep parameters, comparing to placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Zaleplon AP formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jan 2011to Sep 2011
- 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 Primary Insomnia
- Subjects that report a time in bed ≥6.5 and ≤9 hours
- Subjects that report on a one week sleep diary (on at least 3 of 7 nights) TST ≤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) ≥30 minutes time to sleep onset
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- 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 ≤6.5 hours on each of the two nights
- Body mass index of 18 - 34 inclusive
- Subjects that report a median habitual bedtime between 9:00pm (21:00 hours) and 12:00am (00:00) on a one week sleep diary (based on 3 or more nights).
Who cannot join
- Participation in another drug clinical trial within 1 month prior to first screening diary day (calculated from the previous study's last dosing date).
- On screening PSG night 1 an AHI >10 (apnea hypopnea index)
- On screening PSG night 1 a PLMAI ≥10 (periodic limb movements with arousal)
- Subject has a circadian rhythm disorder including shift work or the need to travel ≥3 time zones during the course of the study
- Subject has any other sleep disorder (e.g. Restless Legs Syndrome )
- Use of any drug known to effect sleep or wake functions within 5 half lives of the drug or two weeks, whichever comes first.
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- 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)
- Subject has currently or a significant history of seizures, sleep apnea or restless leg syndrome or other sleep disorders which, in the opinion of the investigator responsible, contraindicates his/her participation
- Subjects with a recent history of clinically defined GERD, peptic ulcer or any gastrointestinal surgery other than appendectomy or herniotomy which, in the opinion of the investigator responsible, contraindicates his/her participation
- Subject with any gastrointestinal disorder likely to influence drug absorption, or with any history of inflammatory bowel disease, intestinal obstruction, irritable bowel syndrome, severe gastrointestinal narrowing, or frequent nausea or emesis, regardless of etiology which, in the opinion of the investigator responsible, contraindicates his/her participation
- Subjects suffering from any Axis 1 Psychiatric Disorder that in the opinion of the investigator responsible may interfere with full participation
- Subject has significant history of cardiac, pulmonary, hepatic or renal disease or other condition or any major complication/illness which, in the opinion of the investigator responsible, contraindicates his/her participation.
- The subject has any clinically important abnormal finding as determined by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator
- Subject is taking CNS-active drugs (including herbal products with CNS effects), known to affect the sleep/wake cycle including but not limited to anxiolytic, hypnotics, antidepressants, sedating H1 antihistamines, systemic steroids, anticonvulsants, narcotic analgesics, respiratory stimulants respiratory decongestants, OTC and prescription diet aids, OTC and prescription stimulants, St. John's Wort, and melatonin.
- Females who are pregnant or nursing.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Miami Research Associates
Miami, Florida
Vince and Associates Clinical Research
Overland Park, Kansas
Broward Research Group
Pembroke Pines, Florida
Pacific Sleep Medicine
San Diego, California
CRG of St. Petersburg
St. Petersburg, Florida
About this study
Official title: Double Blind, Polysomnographic, Two-Way Crossover Study To Compere The Efficacy Of Gastric Retentive Zaleplon (Zaleplon AP) To Placebo In Subjects With Insomnia Characterized By Both Difficulty In Falling Asleep And Staying Asleep
This is a multi center, double blind placebo controlled, two-way crossover study in patients with Insomnia suffering from difficulty in falling asleep and staying asleep. This study intends to assess the efficacy of Zaleplon AP in improving sleep parameters, comparing to placebo.
- Conditions
- Insomnia
- Being tested
- Zaleplon AP formulation, Placebo capsule
- Keywords
- PSG, LPS, TST, WASO, Subjects With Insomnia characterized by both Difficulty in Falling Asleep and Staying Asleep
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zaleplon AP formulationDrug
Gastric retentive dual release Zaleplon
Placebo capsuleDrug
Identical placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Zaleplon AP formulation | Experimental | Gastric Retentive Dual Release Zaleplon (Zaleplon AP) Receives: Drug: Zaleplon AP formulation |
| Placebo | Placebo comparator | Identical placebo capsule Receives: Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of dual release Zaleplon (Zaleplon AP) on Total Sleep Time (TST)
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.
Measured: Polysomnography tests for 2 consecutive nights at each treatment arm
Secondary outcomes (3)
To determine the efficacy of Zaleplon AP on Latency to Persistent Sleep (LPS)
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.
Measured: Polysomnography tests for 2 consecutive nights at each treatment arm
To determine the efficacy of Zaleplon AP on Wake time After Sleep Onset (WASO)
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.
Measured: Polysomnography tests for 2 consecutive nights at each treatment arm
To evaluate the presence of any residual effects using the digital symbol substitution test (DSST) and a memory test
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.
Measured: 2 consecutive mornings at each treatment arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intec Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277107
- Sponsor's protocol ID
- IN 09 006
- Status last verified
- Dec 2014
- First submitted
- 12 Jan 2011
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Polysomnographic, Two-Way Crossover Study To Compere The Efficacy Of Gastric Retentive Zaleplon (Zaleplon AP) To Placebo In Subjects With Insomnia Characterized By Both Difficulty In Falling Asleep And Staying Asleep
- ClinicalTrials.gov ID
- NCT01277107
- Acronym / sponsor ID
- IN 09 006
- Conditions
- Insomnia
- Keywords
- PSG, LPS, TST, WASO, Subjects With Insomnia characterized by both Difficulty in Falling Asleep and Staying Asleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Intec Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Jan 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 is a multi center, double blind placebo controlled, two-way crossover study in patients with Insomnia suffering from difficulty in falling asleep and staying asleep. This study intends to assess the efficacy of Zaleplon AP in improving sleep parameters, comparing to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zaleplon AP formulation | Experimental | Drug: Zaleplon AP formulationGastric Retentive Dual Release Zaleplon (Zaleplon AP) |
| Placebo | Placebo comparator | Drug: Placebo capsuleIdentical placebo capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects between the ages of 18 and 65 years of age
- Subjects that meet DSM IV diagnostic criteria for Primary Insomnia
- Subjects that report a time in bed ≥6.5 and ≤9 hours
- Subjects that report on a one week sleep diary (on at least 3 of 7 nights) TST ≤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 (17 listed)
- Participation in another drug clinical trial within 1 month prior to first screening diary day (calculated from the previous study's last dosing date).
- On screening PSG night 1 an AHI >10 (apnea hypopnea index)
- On screening PSG night 1 a PLMAI ≥10 (periodic limb movements with arousal)
- Subject has a circadian rhythm disorder including shift work or the need to travel ≥3 time zones during the course of the study
- Subject has any other sleep disorder (e.g. Restless Legs Syndrome )
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 |
|---|---|---|
| Zaleplon AP formulationGastric retentive dual release Zaleplon | Drug | Zaleplon AP formulation |
| Placebo capsuleIdentical placebo capsule | Drug | Placebo |
Primary outcome
To determine the effect of dual release Zaleplon (Zaleplon AP) on Total Sleep Time (TST)
Time frame: Polysomnography tests for 2 consecutive nights at each treatment arm
The change from baseline on the mean of drug nights 1 and 2 relative to placebo.
3 secondary outcomes
To determine the efficacy of Zaleplon AP on Latency to Persistent Sleep (LPS)
Time frame: Polysomnography tests for 2 consecutive nights at each treatment arm
To determine the efficacy of Zaleplon AP on Wake time After Sleep Onset (WASO)
Time frame: Polysomnography tests for 2 consecutive nights at each treatment arm
To evaluate the presence of any residual effects using the digital symbol substitution test (DSST) and a memory test
Time frame: 2 consecutive mornings at each treatment arm
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 Dec 2014.
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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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zaleplon AP formulation in people with Insomnia, run by Intec Pharma Ltd. at 6 sites in 2 countries.
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 11 inclusion and 17 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 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, 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?
To determine the effect of dual release Zaleplon (Zaleplon AP) on Total Sleep Time (TST) (time frame: Polysomnography tests for 2 consecutive nights at each treatment arm). 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 Dec 2014.