ConstipationPhase 4NCT00712543

A Preference Study Comparing Kristalose® and Liquid Lactulose

A Phase 4 study testing lactulose (Kristalose®) and liquid lactulose in people with Constipation, run by Cumberland Pharmaceuticals at 3 sites in United States.

Completed

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

Official record

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Trial summary

This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Constipation
What is being tested?: lactulose (Kristalose®) and liquid lactulose
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 3 sitesUnited States
Study dates: Jun 2009to Sep 2009
Phase: Phase 4
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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with recently diagnosed chronic constipation requiring treatment.

Who cannot join

Patients with galactosemia (galactose-sensitive diet).
Patients less than 18 years of age.
Patients currently on lactulose therapy.
Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Arya Gastroenterology Associates
Brooklyn, New York, 11237
Rapid Medical Research
Cleveland, Ohio, 44122
Wake Research Associates
Raleigh, North Carolina, 27612

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About this study

Official title: A Preference Study Comparing Kristalose® and Liquid Lactulose in the Treatment of Constipation

This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.

Read the detailed description

This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.

Conditions: Constipation
Being tested: lactulose (Kristalose®), liquid lactulose
Keywords: constipation, laxative, lactulose, Kristalose®
Medical subject headings: Constipation

What participants receive

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

lactulose (Kristalose®)Drug
Also called Kristalose®
Crystals to be dissolved in water and taken as prescribed.
liquid lactuloseDrug
Liquid to be taken as prescribed.

Study groups in NCT00712543
Study group	Role	What they receive
1	Experimental	Kristalose®, as prescribed, for 7 days. Receives: Drug: lactulose (Kristalose®)
2	Experimental	Liquid lactulose, as prescribed, for 7 days. Receives: Drug: liquid lactulose

What is being measured

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

Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
Measured: 14 days

Timeline

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

Jun 2009Sep 2009

First posted10 Jul 2008 (estimated)
Study startJun 2009
Primary completionSep 2009
Study completionSep 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 ConstipationStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00712543
Sponsor's protocol ID: KR-001
Status last verified: Aug 2011
First submitted: 8 Jul 2008
Last updated: 27 Sep 2011
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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Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Preference Study Comparing Kristalose® and Liquid Lactulose in the Treatment of Constipation
ClinicalTrials.gov ID: NCT00712543
Acronym / sponsor ID: KR-001
Conditions: Constipation
Keywords: constipation, laxative, lactulose, Kristalose®
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 10 Jul 2008 (estimated)
Results: Posted 27 Sep 2011

Clinical summary

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

This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.

Detailed description

This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: lactulose (Kristalose®)Kristalose®, as prescribed, for 7 days.
2	Experimental	Drug: liquid lactuloseLiquid lactulose, as prescribed, for 7 days.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients with recently diagnosed chronic constipation requiring treatment.

Key exclusion criteria (4 listed)

Patients with galactosemia (galactose-sensitive diet).
Patients less than 18 years of age.
Patients currently on lactulose therapy.
Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions.

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
lactulose (Kristalose®)Also: Kristalose®Crystals to be dissolved in water and taken as prescribed.	Drug	1
liquid lactuloseLiquid to be taken as prescribed.	Drug	2

Primary outcome

Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.
Time frame: 14 days

Results and safety

Results posted to the registry on 27 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Powder, Then Liquid Lactulose	23	23
Liquid, Then Powder Lactulose	27	27

Primary outcome: Patient Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability.

Time frame: 14 days. Number. Unit: participants

Measure	Powder, Then Liquid Lactulose n = 23	Liquid, Then Powder Lactulose n = 27
Preferred liquid lactulose overall	7	6
Preferred powder lactulose overall	12	11
No preference overall	4	8
Preferred liquid lactulose in terms of taste	7	9
Preferred powder lactulose in terms of taste	12	11
No preference in terms of taste	4	5
Preferred liquid lactulose in terms of consistency	7	7
Preferred powder lactulose in terms of consistency	11	11

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Powder, Then Liquid Lactulose	0 of 50 (0%)	13 of 50 (26%)	Not reported
Liquid, Then Powder Lactulose	0 of 50 (0%)	10 of 50 (20%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2011.
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.

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 4 study testing lactulose (Kristalose®) and liquid lactulose in people with Constipation, run by Cumberland Pharmaceuticals at 3 sites in United States.

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 1 inclusion and 4 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 27 Sep 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 United States. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2011). 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 Preference in Terms of Overall Preference and Preference of Taste, Consistency, and Portability. (time frame: 14 days). 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 NCT00712543.

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 27 Sep 2011.