Sleep DisordersPANDANCT00830115

Pantoprazole 20/40 mg in the Treatment of Symptomatic Reflux Disease With Focus on Sleep Disorders

An observational study of Sleep Disorders and Non-Erosive Reflux Disease, run by Nycomed at 201 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of the study was to evaluate the effect of pantoprazole on sleep disorders in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease). The prevalence and intensity of the sleep disorders were evaluated by a standardized questionnaire. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Sleep Disorders, Non-Erosive Reflux Disease, Gastroesophageal Reflux Disease
What is being tested?: Pantoprazole
How many people: 1,045 participants
Where: 201 sitesGermany
Study dates: Jan 2009to Jun 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Outpatients

Main inclusion criteria:

Outpatients with erosive gastro-esophageal reflux disease (eGERD) or non-erosive reflux disease (NERD)

Main exclusion criteria:

Criteria as defined in the respective Summary of Product Characteristics (Chapter 4.3)

Trial locations and contacts

201 sites in 1 country.

City, postcode or hospital

201 sites in 1 country

Germany201 sites

Nycomed Deutschland GmbH
Aachen, 52078
Nycomed Deutschland GmbH
Ahrensburg, 22926
Nycomed Deutschland GmbH
Altenburg, 04600
Nycomed Deutschland GmbH
Ansbach, 91522
Nycomed Deutschland GmbH
Aschaffenburg, 63739
Nycomed Deutschland GmbH
Augsburg, 86150
Nycomed Deutschland GmbH
Bad Bederkesa, 27624
Nycomed Deutschland GmbH
Bad Doberan, 18209
Nycomed Deutschland GmbH
Bad Essen, 49152
Nycomed Deutschland GmbH
Bad Kissigen, 97688
Nycomed Deutschland GmbH
Bassum, 27211
Nycomed Deutschland GmbH
Beckum-Neubeckum, 59269
Nycomed Deutschland GmbH
Bergkamen, 59192
Nycomed Deutschland GmbH
Berlin, 10707
Nycomed Deutschland GmbH
Berlin, 10713
Nycomed Deutschland GmbH
Berlin, 10719
Nycomed Deutschland GmbH
Berlin, 12043
Nycomed Deutschland GmbH
Berlin, 12437
Nycomed Deutschland GmbH
Berlin, 12587
Nycomed Deutschland GmbH
Berlin, 12621
Nycomed Deutschland GmbH
Berlin, 12627
Nycomed Deutschland GmbH
Berlin, 13051
Nycomed Deutschland GmbH
Berlin, 13125
Nycomed Deutschland GmbH
Bietigheim, 74321
Nycomed Deutschland GmbH
Bitterfeld-Wolfen, 06749
Nycomed Deutschland GmbH
Bochum, 44787
Nycomed Deutschland GmbH
Bochum, 44791
Nycomed Deutschland GmbH
Bodenwerder, 37619
Nycomed Deutschland GmbH
Bovenden, 37120
Nycomed Deutschland GmbH
Bramsche, 49565
Nycomed Deutschland GmbH
Brandenburg, 14776
Nycomed Deutschland GmbH
Bredstedt, 25821
Nycomed Deutschland GmbH
Bremen, 28359
Nycomed Deutschland GmbH
Bremen, 28755
Nycomed Deutschland GmbH
Bremerhaven, 27570
Nycomed Deutschland GmbH
Butzbach, 35510
Nycomed Deutschland GmbH
Castrop-Rauxel, 44577
Nycomed Deutschland GmbH
Chemnitz, 09111
Nycomed Deutschland GmbH
Chemnitz, 09117
Nycomed Deutschland GmbH
Chemnitz, 09130
Nycomed Deutschland GmbH
Clenze, 29459
Nycomed Deutschland GmbH
Coburg, 96450
Nycomed Deutschland GmbH
Cölbe, 35091
Nycomed Deutschland GmbH
Cologne, 50679
Nycomed Deutschland GmbH
Cologne, 50999
Nycomed Deutschland GmbH
Cottbus, 03046
Nycomed Deutschland GmbH
Cottbus, 03048
Nycomed Deutschland GmbH
Crailsheim, 74564
Nycomed Deutschland GmbH
Darmstadt, 64293
Nycomed Deutschland GmbH
Deggendorf, 94469
Nycomed Deutschland GmbH
Dessau, 06844
Nycomed Deutschland GmbH
Dinkelsbühl, 91550
Nycomed Deutschland GmbH
Dippoldswalde, 01744
Nycomed Deutschland GmbH
Dortmund, 44269
Nycomed Deutschland GmbH
Dresden, 01067
Nycomed Deutschland GmbH
Dresden, 01127
Nycomed Deutschland GmbH
Dresden, 01307
Nycomed Deutschland GmbH
Dresden, 01324
Nycomed Deutschland GmbH
Eisenach, 99817
Nycomed Deutschland GmbH
Ellefeld, 08236
Nycomed Deutschland GmbH
Erfurt, 99084
Nycomed Deutschland GmbH
Erlenbach, 63906
Nycomed Deutschland GmbH
Eschweiler, 52249
Nycomed Deutschland GmbH
Essen, 45138
Nycomed Deutschland GmbH
Essen, 45355
Nycomed Deutschland GmbH
Esslingen am Neckar, 73730
Nycomed Deutschland GmbH
Flensburg, 24939
Nycomed Deutschland GmbH
Frankfurt, 60389
Nycomed Deutschland GmbH
Freiburg im Breisgau, 79104
Nycomed Deutschland GmbH
Freising, 85356
Nycomed Deutschland GmbH
Freudenstadt, 72250
Nycomed Deutschland GmbH
Fürstenzell, 94081
Nycomed Deutschland GmbH
Fürth, 90762
Nycomed Deutschland GmbH
Gardelegen, 39638
Nycomed Deutschland GmbH
Gera, 07545
Nycomed Deutschland GmbH
Gera, 07546
Nycomed Deutschland GmbH
Goch, 47574
Nycomed Deutschland GmbH
Goslar, 38640
Nycomed Deutschland GmbH
Greifsfeld, 17489
Nycomed Deutschland GmbH
Greifswald, 17489
Nycomed Deutschland GmbH
Grevenbroich, 41515
Nycomed Deutschland GmbH
Grimmen, 18507
Nycomed Deutschland GmbH
Großaitingen, 86845
Nycomed Deutschland GmbH
Güstrow, 18273
Nycomed Deutschland GmbH
Halberstadt, 38820
Nycomed Deutschland GmbH
Halle, 06108
Nycomed Deutschland GmbH
Hamburg, 21107
Nycomed Deutschland GmbH
Hamburg, 22459
Nycomed Deutschland GmbH
Hamburg, 22529
Nycomed Deutschland GmbH
Hanover, 30449
Nycomed Deutschland GmbH
Hanover, 30455
Nycomed Deutschland GmbH
Hanover, 30625
Nycomed Deutschland GmbH
Harra, 07366
Nycomed Deutschland GmbH
Haßfurt, 97437
Nycomed Deutschland GmbH
Haßloch, 67454
Nycomed Deutschland GmbH
Hechingen, 72379
Nycomed Deutschland GmbH
Heide, 25746
Nycomed Deutschland GmbH
Henstedt-Ulzburg, 24558
Nycomed Deutschland GmbH
Hildesheim, 31134
Nycomed Deutschland GmbH
Hof, 95028
Nycomed Deutschland GmbH
Holzgerlingen, 71088
Nycomed Deutschland GmbH
Ibbenbueren, 49477
Nycomed Deutschland GmbH
Johanngeorgenstadt, 08349
Nycomed Deutschland GmbH
Karlstadt am Main, 97753
Nycomed Deutschland GmbH
Kassel, 34117
Nycomed Deutschland GmbH
Kelkheim, 65779
Nycomed Deutschland GmbH
Kiel, 24103
Nycomed Deutschland GmbH
Koblenz, 56068
Nycomed Deutschland GmbH
Kornwestheim, 70806
Nycomed Deutschland GmbH
L.-E.-Musberg, 70771
Nycomed Deutschland GmbH
Landstuhl, 66849
Nycomed Deutschland GmbH
Leer, 26789
Nycomed Deutschland GmbH
Leipzig, 04103
Nycomed Deutschland GmbH
Leipzig, 04105
Nycomed Deutschland GmbH
Leipzig, 04129
Nycomed Deutschland GmbH
Leverkusen, 51375
Nycomed Deutschland GmbH
Lichtenfels, 96215
Nycomed Deutschland GmbH
Limburg, 65549
Nycomed Deutschland GmbH
Lingen, 49809
Nycomed Deutschland GmbH
Lübeck, 23570
Nycomed Deutschland GmbH
Lüdenscheid, 58507
Nycomed Deutschland GmbH
Ludwigsfelde, 14974
Nycomed Deutschland GmbH
Ludwigshafen, 67971
Nycomed Deutschland GmbH
Ludwigshaven-Oggersheim, 67071
Nycomed Deutschland GmbH
Magdeburg, 39130
Nycomed Deutschland GmbH
Mainz, 55116
Nycomed Deutschland GmbH
Mannheim, 68165
Nycomed Deutschland GmbH
Mannheim, 68309
Nycomed Deutschland GmbH
Marienberg, 09496
Nycomed Deutschland GmbH
Marl, 45772
Nycomed Deutschland GmbH
Merseburg, 06217
Nycomed Deutschland GmbH
Merzig-Schwemlingen, 66663
Nycomed Deutschland GmbH
Mettlach, 66693
Nycomed Deutschland GmbH
Minden, 32423
Nycomed Deutschland GmbH
Minden, 32427
Nycomed Deutschland GmbH
Möckmühl, 74219
Nycomed Deutschland GmbH
Mönchnegladbach, 41236
Nycomed Deutschland GmbH
München, 80331
Nycomed Deutschland GmbH
München, 80337
Nycomed Deutschland GmbH
München, 81369
Nycomed Deutschland GmbH
Münzenberg, 35516
Nycomed Deutschland GmbH
Neckargemünd, 69151
Nycomed Deutschland GmbH
Neu Wulmstorf, 21629
Nycomed Deutschland GmbH
Neu-Isenburg, 63263
Nycomed Deutschland GmbH
Neukirchen, 08459
Nycomed Deutschland GmbH
Neuruppin, 16816
Nycomed Deutschland GmbH
Neustadt an der Orla, 07806
Nycomed Deutschland GmbH
Neustadt in Sachsen, 01844
Nycomed Deutschland GmbH
Nieder-Olm, 55268
Nycomed Deutschland GmbH
Nordhausen, 99734
Nycomed Deutschland GmbH
Oberhausen, 46045
Nycomed Deutschland GmbH
Oberndorf, 78727
Nycomed Deutschland GmbH
Ochsenfurt, 97199
Nycomed Deutschland GmbH
Oelsnitz/Erzgeb., 09376
Nycomed Deutschland GmbH
Oldenburg, 26122
Nycomed Deutschland GmbH
Paderborn, 33098
Nycomed Deutschland GmbH
Papenburg, 26871
Nycomed Deutschland GmbH
Penig, 09322
Nycomed Deutschland GmbH
Plauen, 08523
Nycomed Deutschland GmbH
Plettenberg, 58840
Nycomed Deutschland GmbH
Potsdam, 14471
Nycomed Deutschland GmbH
Potsdam, 14480
Nycomed Deutschland GmbH
Potsdam, 14482
Nycomed Deutschland GmbH
Recklinghausen, 45659
Nycomed Deutschland GmbH
Regensburg, 93059
Nycomed Deutschland GmbH
Remscheid, 42859
Nycomed Deutschland GmbH
Riesa, 01587
Nycomed Deutschland GmbH
Rostock, 17147
Nycomed Deutschland GmbH
Rottach, 83700
Nycomed Deutschland GmbH
Rottweil, 78628
Nycomed Deutschland GmbH
Saarbrücken, 66128
Nycomed Deutschland GmbH
Saarlouis, 66740
Nycomed Deutschland GmbH
Saint Blasien, 79837
Nycomed Deutschland GmbH
Salzgitter, 38259
Nycomed Deutschland GmbH
Schiffweiler, 66578
Nycomed Deutschland GmbH
Schmalkalden, 98574
Nycomed Deutschland GmbH
Schwäbisch Hall, 74523
Nycomed Deutschland GmbH
Schwarmstedt, 29690
Nycomed Deutschland GmbH
Schwerin, 19053
Nycomed Deutschland GmbH
Sondeshausen, 99706
Nycomed Deutschland GmbH
Spaichingen, 78549
Nycomed Deutschland GmbH
Steinfurt, 48565
Nycomed Deutschland GmbH
Steißlingen, 78256
Nycomed Deutschland GmbH
Stockach, 78333
Nycomed Deutschland GmbH
Strausberg, 15344
Nycomed Deutschland GmbH
Sundern, 59846
Nycomed Deutschland GmbH
Tapfheim, 86660
Nycomed Deutschland GmbH
Varel, 26316
Nycomed Deutschland GmbH
Waghäusel, 68753
Nycomed Deutschland GmbH
Wangen, 88239
Nycomed Deutschland GmbH
Wanzleben, 39164
Nycomed Deutschland GmbH
Weißenburg, 91781
Nycomed Deutschland GmbH
Weißenfels, 06667
Nycomed Deutschland GmbH
Wiesbaden, 65185
Nycomed Deutschland GmbH
Willich, 47877
Nycomed Deutschland GmbH
Wismar, 23966
Nycomed Deutschland GmbH
Wittenberg, 06886
Nycomed Deutschland GmbH
Zell, 56856
Nycomed Deutschland GmbH
Zerbst, 39261
Nycomed Deutschland GmbH
Zweibrücken, 66482
Nycomed Deutschland GmbH
Zwickau, 08056

Other trials in Germany

About this study

Official title: Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders

Conditions: Sleep Disorders, Non-Erosive Reflux Disease, Gastroesophageal Reflux Disease
Being tested: Pantoprazole
Keywords: PPI therapy, Pantoprazole, eGERD (Erosive Gastroesophageal Reflux Disease), NERD (Non-Erosive Reflux Disease)
Medical subject headings: Sleep Wake Disorders, Non-Erosive Reflux Disease, Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PantoprazoleDrug
Observational, non-interventional study (NIS). The physician decided about dosage according to individual needs (20 or 40 mg pantoprazole, once daily).

Study groups in NCT00830115
Study group	Role	What they receive
Pantoprazole		All patients enrolled Receives: Drug: Pantoprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)
Assessment on a scale from 1=Feeling active, vital, alert, or wide awake to 7=No longer fighting sleep, sleep onset soon, having dream-like thoughts
Measured: 7 days
Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Measured: 7 days
Physician's Assessment of Sleep Disturbances
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Measured: 7 days

Secondary outcomes (10)

Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)
Assessment on a scale: Severity from 1=Excellent to 10=Extremely bad
Measured: 7 days
Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Measured: 7 days
Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Measured: 7 days
Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Measured: 7 days
Patient's Assessment of Nausea for the Last 24 Hours (Diaries)
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Measured: 7 days
Physician's Assessment of Heartburn
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Measured: 7 days
Physician's Assessment of Acid Eructation
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Measured: 7 days
Physician's Assessment of Painful Swallowing
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe
Measured: 7 days
Assessment of the Efficacy of Pantoprazole at Final Visit
Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Measured: 7 days
Assessment of the Tolerability of Pantoprazole at Final Visit
Assessment on a scale: 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Jun 2009

First posted27 Jan 2009 (estimated)
Study startJan 2009
Primary completionMay 2009
Study completionJun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sleep DisordersStudies 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 1,045 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00830115
Sponsor's protocol ID: P2-9999-010-DE
Acronym: PANDA
Status last verified: May 2012
First submitted: 13 Jan 2009
Last updated: 8 May 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sleep Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders
ClinicalTrials.gov ID: NCT00830115
Acronym / sponsor ID: PANDA / P2-9999-010-DE
Conditions: Sleep Disorders, Non-Erosive Reflux Disease, Gastroesophageal Reflux Disease
Keywords: PPI therapy, Pantoprazole, eGERD (Erosive Gastroesophageal Reflux Disease), NERD (Non-Erosive Reflux Disease)
Study type: Observational
Recruitment status: Completed
Enrolment: 1,045 participants (actual)
Lead sponsor: NycomedIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: May 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 27 Jan 2009 (estimated)
Results: Posted 15 Sep 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Pantoprazole	–	Drug: PantoprazoleAll patients enrolled

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Outpatients

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
PantoprazoleObservational, non-interventional study (NIS). The physician decided about dosage according to individual needs (20 or 40 mg pantoprazole, once daily).	Drug	Pantoprazole

Primary outcome

Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)
Time frame: 7 days
Assessment on a scale from 1=Feeling active, vital, alert, or wide awake to 7=No longer fighting sleep, sleep onset soon, having dream-like thoughts
Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)
Time frame: 7 days
Assessment on a scale: Severity from 1=Not impaired to 10=Severely impaired
Physician's Assessment of Sleep Disturbances
Time frame: 7 days
Assessment on a scale: 1=none, 2=mild, 3=moderate, 4=severe

10 secondary outcomes

Patient's Assessment of General Well-being for the Last 24 Hours (Diaries)
Time frame: 7 days
Patient's Assessment of Acid Complaints for the Last 24 Hours (Diaries)
Time frame: 7 days
Patient's Assessment of Upper-abdominal/Stomach Complaints for the Last 24 Hours (Diaries)
Time frame: 7 days
Patient's Assessment of Lower Abdominal/Digestive Complaints for the Last 24 Hours (Diaries)
Time frame: 7 days
Patient's Assessment of Nausea for the Last 24 Hours (Diaries)
Time frame: 7 days
Physician's Assessment of Heartburn
Time frame: 7 days
Physician's Assessment of Acid Eructation
Time frame: 7 days
Physician's Assessment of Painful Swallowing
Time frame: 7 days
Assessment of the Efficacy of Pantoprazole at Final Visit
Time frame: 7 days
Assessment of the Tolerability of Pantoprazole at Final Visit
Time frame: 7 days

Results and safety

Results posted to the registry on 15 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pantoprazole	1,045	1,042

Primary outcome: Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries)

Time frame: 7 days. Mean (Standard Deviation). Unit: Units on a scale

Measure	Pantoprazole n = 869
Day 0	2.94 (1.58)
Day 1	2.62 (1.41)
Day 2	2.28 (1.23)
Day 3	2.03 (1.12)
Day 4	1.86 (1.06)
Day 5	1.74 (1.02)
Day 6	1.67 (1.01)

Population analysed: All patients included and treated, intention to treat, missing values not imputed ('as observed'). Number of valid cases: * Day 0 = 869 * Day 1 = 868 * Day 2 = 867 * Day 3 = 864 * Day 4 = 863 * Day 5 = 859 * Day 6 = 862

Primary outcome: Patient's Assessment of Sleep Disturbances for the Last 24 Hours (Diaries)

Time frame: 7 days. Mean (Standard Deviation). Unit: Units on a scale

Measure	Pantoprazole n = 846
Day 0	3.65 (2.39)
Day 1	3.07 (2.11)
Day 2	2.53 (1.84)
Day 3	2.21 (1.65)
Day 4	2.00 (1.54)
Day 5	1.78 (1.42)
Day 6	1.68 (1.34)

Population analysed: All patients included and treated, intention to treat, missing values not imputed ('as observed'). Number of valid cases: * Day 0 = 846 * Day 1 = 841 * Day 2 = 828 * Day 3 = 817 * Day 4 = 800 * Day 5 = 791 * Day 6 = 790

Primary outcome: Physician's Assessment of Sleep Disturbances

Time frame: 7 days. Mean (Standard Deviation). Unit: Units on a scale

Measure	Pantoprazole n = 1011
Start of therapy	2.03 (0.94)
End of study	1.26 (0.54)

Population analysed: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: First until last intake (planned 7 days). Other adverse events reported at 0.1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pantoprazole	0 of 1,045 (0%)	4 of 1,045 (0.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Thomas Bethke, MD, MBA study director

Nycomed Deutschland GmbH, 78467 Konstanz, Germany

201 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Disorders and Non-Erosive Reflux Disease, run by Nycomed at 201 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 201 sites in Germany. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Patient's Assessment of Stanford Sleepiness Scale for the Last 24 Hours (Diaries) (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00830115.

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 8 May 2012.