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Opioid Induced ConstipationPhase 4NCT01957046

A Single-arm, Study to Assess the Effect and Tolerability of Standardised Laxative Therapy (SLT) for the Reversal of Opioid-induced Constipation (OIC).

A Phase 4 study testing Laxative in people with Opioid Induced Constipation, run by Mundipharma Research GmbH & Co KG at 1 site in Sweden.

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

The main purpose of this study is to assess how effective and tolerable the country specific clinical practice guidelines of SLTs are for UK, France and Sweden are. The main rationale behind this study is that well controlled comparisons of the various laxatives for the treatment of OIC are lacking. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Opioid Induced Constipation
What is being tested?
Laxative
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
1 siteSweden
Study dates
Oct 2013to Feb 2015
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects at least 18 years
  • Females less than one year post-menopausal must have a negative pregnancy test prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study. (A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly e.g. sterilisation, implants, injectables, combined oral contraceptives, some intrauterine devices ((IUDs), hormonal), sexual abstinence or vasectomised partner).
  • Documented history of malignant or non-malignant pain that requires around-the-clock opioid therapy (WHO step II/III opioid analgesics).
  • Subjects treated with WHO step II/III opioid analgesics for at least 2 weeks prior to Screening Visit (Visit 1), who will continue with the opioid(s) over the proposed study period.
  • Subjects meeting the following criteria for OIC:
  • Subject and Investigator confirm that the Subject's constipation is induced, or worsened by the Subject's opioid medication (present at Screening)
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  • Subjects with mean BFI score > 30 at Visit 1
  • Subjects with < 3 complete bowel movements (CBMs) in the week preceding the Visit 1, based on Subject's retrospective memory in response to Investigator's question.
  • Subjects taking at least one laxative on regular basis (i.e. ≥2 intakes per week during the ≥2 weeks prior to screening) for the treatment of OIC.
  • Subjects must be willing to take SLT.
  • Subjects taking daily natural dietary fibre supplementation are eligible if they can maintain their diet throughout the study, and in the Investigator's opinion are willing and able to maintain adequate hydration.
  • Subjects must be willing and able (e.g. mental and physical condition) to participate in all aspects of the study, including use of medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements as evidenced by providing written, informed consent.
  • In the Investigator's opinion the Subject's concomitant medication dose will remain stable throughout the study Period (here concomitant medications mean all medications besides opioids (standard and rescue opioid treatment)).

Who cannot join

  • Medical Conditions:
  • In the Investigator's opinion any contraindication and precautionary condition for laxative medication(s) used in the study as per the SmPC.
  • Subjects having any potential non-opioid cause of constipation that might be a major contributor.
  • Surgery within 2 months prior to the start of the Screening Visit (Visit 1), or planned surgery during the Screening and Treatment periods that may affect GI motility.
  • Subjects with colostomy or ileostomy.
  • Hospitalisation expected/planned within the study Period (e.g. planned hospitalisation for the treatment of a pre-existing condition before informed consent) which can affect the outcome measure analysis.
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  • Treatments/Medications:
  • Subjects presently taking, or who have taken opioid antagonist(e.g. naloxone, naltrexone and methylnaltrexone) or opioid antagonists containing products (e.g. oxycodone/naloxone, buprenorphine/naloxone, pentazocine/naloxone, tilidine/naloxone) < 30 days prior to the start of the Screening Period.
  • Subjects already taking maximum daily dose of country specific SLT (both First and Second Line SLT) on a regular basis (i.e. ≥4 days per week) for the treatment of OIC.
  • Subjects receiving opioid substitution therapy for opioid addiction (e.g. methadone or buprenorphine).
  • Additional Screening Exclusion Criteria for Subjects Suffering from Non-malignant Pain:
  • Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry
  • Additional Screening Exclusion Criteria for Subjects Suffering from Malignant Pain:
  • Subjects who have received a new chemical entity or an experimental drug within 30 days of study entry (defined as Visit 1). Concurrent participation in another clinical trial is not permitted except the epidemiological study performed to assess the long-term survival data.
  • Subjects with an expected life expectancy of < 3 months.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Clinical Research Support

    Örebro

Other trials in Sweden

About this study

Official title: A Single-arm, Open-label, Multicentre, Non-randomised, Study to Assess the Effect and Tolerability of Standardised Laxative Therapy for the Reversal of Opioid-induced Constipation in Subjects Suffering From Malignant or Non-malignant Pain That Requires Around-the-clock Opioid Therapy

The main purpose of this study is to assess how effective and tolerable the country specific clinical practice guidelines of SLTs are for UK, France and Sweden are.

The main rationale behind this study is that well controlled comparisons of the various laxatives for the treatment of OIC are lacking. There is lack of evidence suggesting which laxative or combination of laxatives is optimal for managing OIC.

Read the detailed description

The study comprises of nine study visits and the total duration of the study is up to 42-52 days Potential subjects, aged 18 years and over, with OIC will be screened for entry into the study at Visit 1 Eligible subjects will attend a 7-day Screening Period (Visit 1). This will be followed by a 28-day Treatment Period (visits 2 to 8:), made up of four clinic visits scheduled 7 days apart (visits 5(day 7), 6(day 14), 7(day 21), 8(day 28): days 7 to 28) and two telephone visits (visits 3 and 4) which will take place during the first week of the Treatment Period. There will be a 7-day Follow-up Period with a follow-up phone call to conclude the study (Visit 9).

Study assessment/ evaluation include vital sign measurements, ECG, safety labs, pregnancy test and physical examination assessments, AEs, Investigator and subject questionnaires and subjects daily diaries.

Subjects will continue to take their prescribed pre-study opioid medication throughout the study.

Being tested
Laxative
Keywords
Opioid induced constipation, Laxatives
Medical subject headings
Opioid-Induced Constipation

What participants receive

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

  • LaxativeDrug

Study groups in NCT01957046
Study groupRoleWhat they receive
Oral LaxativeOtherNot described
Receives: Drug: Laxative

What is being measured

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

  1. Change from baseline in soft complete bowel movements

    Recorded in patient diary as and when occurs

    Measured: Change from baseline

Secondary outcomes (14)

  1. Change from baseline (Visit 2 to 8 (Day 1 to 28)) in SCBM - Non Straining

    Measured: change from baseline

  2. Additional laxative use (including enema) in addition to SLT (First Line and Second Line)

    Measured: between visits and overall

  3. Additional procedures (e.g. manual bowel evacuation or surgical procedure) required in addition to SLT

    Measured: between visits and overall

  4. Bowel Function Index (change from baseline to each visit (Day 7, 14, 21 and 28))

    Measured: change from baseline

  5. Compliance with SLT/opioid therapy (premature discontinuation, SLT/opioid dose reduction or completely stopped SLT/opioid therapy).

    Measured: from baseline to end of treatment

  6. SLT/opioid-related AE and dropouts.

    Measured: to end of treatment

  7. The modified Subjective Opiate Withdrawal Scale at Day 7 and Day 28

    Measured: Day 7 and Day 28

  8. The Clinical Opiate Withdrawal Scale at Day 7 and Day 28

    Measured: Day 7 and Day 28

  9. Pain Intensity Scale - "Average Pain over last 24 Hours" at each visit (Day 7, 14, 21 and 28)

    Measured: Day 7, 14, 21 and 28

  10. The 36-item Short Form Health Survey (SF-36 v2) at Day 7 and Day 28

    Measured: Day 7 and 28

  11. Clinical Global Impression (CGI) item 1 (severity) Day 28

    Measured: Day 28

  12. Clinical Global Impression (CGI) item 2-4 (condition, therapeutic effect, side effects) Day 7 amd 28

    Measured: Day 7 and 28

  13. The patient global impression of improvement (PGI-I) Day 28

    Measured: Day 28

  14. Healthcare resources used for OIC treatment during the study (between first dose and last dose during the four week treatment period).

    Measured: overall

Timeline

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

  1. First posted8 Oct 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionAug 2014
  4. Study completionFeb 2015

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01957046
Sponsor's protocol ID
SLT4501
Status last verified
May 2016
First submitted
10 Jul 2013
Last updated
4 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Laxative in people with Opioid Induced Constipation, run by Mundipharma Research GmbH & Co KG at 1 site in Sweden.

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 13 inclusion and 15 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 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. 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?

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?

Change from baseline in soft complete bowel movements (time frame: Change from baseline). 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 NCT01957046.

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 4 May 2016.

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